pharmaceutical gmp resume

Developing and successfully implementing strategies and action plans for establishing and enhancing a competitive contracting approach for Cigna which meets current and future needs of our customers and clients, Build and direct effective strategic relationships, contracting initiatives, and strategies with both brand and generic pharmaceutical manufacturers, Continually explore market to develop new contracting opportunities. Prepares ad hoc reports as requested and maintains/tracks technical and training KPIs. as needed, Support Capital Project actions to ensure compliance of new facility, Proactively identifies areas of continuous improvement in Supplies Inspection, Actively participates in the Tier process and uses this forum to escalate concerns and best practices, Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans, Bachelor's degree. Management role with a Quality and/or R&D function in pharmaceutical industry, Expert knowledge of cGMP/GDP, EMA, & ICH requirements/guidelines, Experience working with R&D organizations, Familiarity with new product development lifecycle - including analytical method development, Solid influencing without authority skills, Experience in developing Quality Systems including CAPA, Deviations, and Change control systems, Ability to work independently while still meeting project goals, Strong problem resolution, judgment, and decision making skills, Proven Project Management Experience skills, Ability to Champion regulatory requirements and balance compliance with product requirements, Previous experience in due diligence and integrations activities an advantage, Previous experience working with external manufacturing organizations (CMOs) an advantage, ASQ certified Black Belt and/or Quality Engineer preferred, Executes (or supervises) the development and validation of analytical methods using multiple analytical techniques including CBPA, HPLC, qPCR, ELISAs, Western blots, protein content assays, etc. Follow all SOP’s and BMR (batch manufacturing records) as written & report according to procedures. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. 1 March 2019. Efficiently partner with other departments locally and globally, Develop and implement short, mid, and long term strategies to ensure scientific excellence, state-of-the-art technologies, and regulatory compliance. Shares expertise, instruments and resources within the limitation of established priorities, Maintains a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state of the art production and analytical methods and acquisition of reasonable and necessary equipment, Makes high quality scientific presentations at internal management, regional and national meetings to help advance Allergan’s image as the thought and product leader in the neuromodulator and eye care field. Retrieves components and equipment from aseptic storage, Assists with Isolator and room cleaning in production areas. Works with accounting to complete final bill reviews prior to final invoice processing. active input on the engineering of lab- and pilot plant tools and equipment), Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Grow the business by developing and introducing new and up-graded products to address product gaps in the market, Product Launches & Support: Conduct competitive product assessments and develop new product or product positioning strategies to compete. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Supervise the technical set up and technical personnel's activities for the Filling, Capping, Participating in pre-FAT testing for new production equipment. Sterile product experience is highly desirable, Experience in robust process development, scale-up, manufacturing and validation, including DOE and QbD, Working knowledge of API synthesis and manufacturing is desirable and ability to liase with synthethic chemistry experts and coordinate API and finished product activities, Knowledge of clinical supplies requirements and regulations, Must have a working knowledge of various analytical methods used during the development of pharmaceutical products, including, but not limited to, HPLC, IR, UV, NMR, Mass Spec., dissolution and tablet hardness, etc., and ability to liase and coordinate development activities with analytical chemistry experts, Experience of early and late stage product development including product stability, product packaging and labeling requirements. Experience with the software development lifecycle, specifically in a validated environment, Prior supervisory and people development experience, Preferred 1 to 2 year’s experience in a pharmaceutical or medical device manufacturing operations, engineering, logistics or quality, Preferred to have some experience in Lean manufacturing principles and / or going through the Black Belt certification process, Ability to anticipate the next processing steps in each manufacturing suite and allocate the appropriate people resources to ensure the production schedule is met, Ability to take current production output standards and determine who/what is preventing from meeting the goal, taking appropriate corrective action, and/or holding those responsible accountable for the misses, Strong leadership skills including being able to provide day to day direction, deliver performance reviews and formal disciplines, Must possess strong written and verbal communication skills, Subject matter expert on their shift for their areas of responsibility, Ability to deliver immediate performance feedback to machine operators operating in assigned areas, Ability to communicate and interact with on-site customers, or their representatives, Capable of making decisions based on both historical data and that achieved through thorough analysis, Must demonstrate working computer knowledge, Total Site Staff (includes directs): Technicians, Room Leaders and Sr. Technicians, Handling of raw materials for product assembly, Lifting boxes and/or containers up to 40 lbs. Performs environmental inspections to the waste area as required, Evaluates process data and performs product sampling and inspections as part of the manufacturing process and quality monitoring, Documents manufacturing and cleaning steps as per SOPs, batch records and batch official forms, including inspection, sampling and process monitoring, Assists technical personnel in equipment and process validation, including performing the required sampling according to approved instructions, Documents shift events and status in logs, as needed, Technical, associate or bachelor’s degree from an accredited institute is preferred, Operate filling and packaging production unit for FDA and EPA regulated and less regulated pharmaceutical products, Organize and perform equipment set-ups for production processes, Perform unit and equipment cleaning procedures, Record information throughout the process into the batch record and/or log books to ensure compliance, Follow proper trouble shooting procedures when malfunctions occur, Follow GMP’s and SOP’s and plant safety guidelines, Must be able to work any shift (1st, 2nd, or 3rd), Talking/listening to others to convey/understand information effectively, Ability to read, understand and execute operating instructions, guidelines, SOPs, and batch records, Prior working experience with FDA, EP & EU regulated products required, Good math skills: adding, subtracting, multiplication, percentages, conversions, Demonstrate ability to work in teams and lead by example, Silver Level WorkKey Assessment required or an Associates or higher degree in lieu of the WorkKey Assessment, Ability to operate equipment in accordance with established safety guidelines and operating parameters, Ability to palletize shippers based on pallet configuration drawings, For the advanced analysis of proteins and their modifications you develop LC-MS methods, You author/review compiled analytical results and provide comprehensive result presentations to project teams, Regarding stakeholders and interfaces (e. g. project teams, line management) you ensure excellent communication, interaction and collaboration, You consult on analytical strategies for samples originating from upstream, downstream and formulation development, Project Management of Pharmaceutical projects through all project phases: planning; preconstruction, construction, commissioning & validation, Cost Forecasting and financial reporting on projects assigned, Management of Change Orders and procurement process, Project Management with high levels of customer satisfaction, Manage projects to completion on-time, within budget and within the scope of work, Manage Client Project Management Information System (PMIS), including monthly updates of project data, Produce reports and briefings using Microsoft Word, Excel and PowerPoint, Bachelor of Science Degree in Engineering, Architecture, Construction Management or Quantity Surveying, Project Management experience in manufacturing or research & development process and/or building projects, 3 to 5 years Cost Management experience in Healthcare/Pharmaceutical process and/or Healthcare/Pharmaceutical building projects, Proficient in Microsoft Word, Excel, PowerPoint, and Outlook, Experience of PMIS systems used to manage capital projects program, Pharmaceutical Facilities/Engineering experience to include office, R&D laboratories, mechanical / electrical infrastructure, central plant, site work, building expansions, BAS, and process controls, Experience in Pharmaceutical building projects ranging up to $10 million in value, Maintain and verify drug inventory controls are at a level to meet customer demand. Clean and maintain process equipment which may include, but not limited to tanks, filler, pumps, blenders, mills, presses, coating pans, etc, Assist with technical troubleshooting and preventive maintenance tasks as needed and trained. $135.00. Maintaining an active rolodex and pipeline of executives and working to maintain, expand, and mature those over time, Identifying and addressing client needs: build, maintain, and utilize networks of client relationships; manage resource requirements, project workflow and budgets, Communicating complex material effectively in written and oral formats to various audiences, Conducting and directing quantitative and qualitative analyses of large and complex data, Administers the receipt, validation, and payment of rebate claims for branded NDCs from insurers, prescription benefit managers (PBMs), and at- risk Medicaid organizations (accounts), Reads and interprets contract terms and conditions concerning rebate eligibility and set parameters in the proprietary contract system (CARS) to accurately calculate each rebate, Processes each claim in accordance with contract language and internal processing procedures, Understands all systems and processes and strives to identify improvements, Assists manager in training and development of claims administration staff, Reviews and interprets rebate contract terms and conditions and establishes parameters in the contracting system (CARS) to produce accurate rebate calculations, Conducts initial quality check, including formulary compliance, on all claim submissions to ensure rebate eligibility. Partner with organization (Sales / BDMs) to ensure development of programs, tools initiatives to improve performance. Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. in particular at relevant decision points, Provide information for new BHC applications,litigation cases and for due diligence, Lead cross-functional teams to implement client solutions w, Leverage and customize proprietary analytics to client needs, resulting in exceptional client value, Manage multiple projects ensuring exceptional client satisfaction and on-time delivery, Make presentations and recommendations to clients on optimal customer, sales and marketing strategies and tactics, Contribute to development of new solutions and analytical models, The Contractor Quality Analyst (CQA) provides Quality support to the Incoming Material Supplies Inspection processing and laboratory areas, The CQA, with guidance from the Incoming Materials IPT Quality Leadership Team, will perform activities that support and ensure process quality and data integrity with incoming sampling of raw materials and inspection of primary packing components, The Contractor Quality Analyst will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to support incoming sampling in Classified D and C processing areas and component inspection, Submit Work Orders to maintain compliance within sampling and component facilities, Update Supplies Inspection protocols, logbooks, etc. - Choose from 15 Leading Templates. The PDTL should take a proactive role in identifying the right questions and providing the appropriate experimental design using relevant preclinical studies and formulation concepts, In case of unsatisfactory developability properties of a lead candidate, provide input into potential development issues and risk factors and recommend the strategy on how to move forward, Proactively connect and interact with key stakeholders within therapeutic areas, Pharmacokinetics, Toxicology, and PDMS, Responsible for the integrated Developability assessment in close collaboration with the PK representatives and PharmSci Representatives, Provide a complete developability assessment package at the time of Development candidate declaration in order to ensure smooth transition of a small molecule from Discovery into the Early Development portfolio, in terms of formulations suitable for (GLP) toxicology studies, and guidance for the formulation strategy for clinical phase-1 studies, Represent Discovery Sciences at review committees, Keep informed on and invest in innovative screening tools and formulation options to meet the needs of the Discovery and early Development programs, in collaboration with experts within PDMS, academic groups and contract labs, Provide strategic and scientific guidance to a team of scientists (developability representatives, formulators) and lab technicians, Take the scientific and strategic lead in shaping the global Pharmaceutical Developability team to fit with the requirements of the organization, to foster collaboration and synergy across multiple teams, and enhance the scientific expertise, A PhD degree in Pharmaceutical Sciences or Chemistry or proven equal experience, with a strong understanding of Pharmaceutical Development, ADME and Preclinical Safety evaluation, A minimum of 7-10 years of experience as a Pharmaceutical Scientist, with demonstrated experience in developability and formulation strategies, is required, Experience in interpretation of pharmaceutical properties in relation to exposure and toxicology data in drug discovery & development, Organizational, planning, problem solving skills and the leadership skills needed in the completion of deliverables to the discovery Teams, Excellent partnering and decision-making skills, Master the balance between nice-to-have and need-to-have, apply fit-for-purpose approaches to provide scientifically valid assessments, Negotiate and influence decision-making processes, think and manage through issues into resolution, lead scientific discussions, Make fast decisions if needed, but at the same time inclusive and excellent team player, Excellent oral and written communication skills and ability to clearly and concisely present and communicate developability assessment and its impact to various audiences, including medicinal chemists, biologists, preclinical leaders (for both Tox and ADME), and internal boards, Ability to connect and empower people, discover and develop potential and challenge in a positive manner where necessary, Experience or interest in Multichannel approach, Ability to plan strategically and logically, Knowledge of the drivers surrounding Community Pharmacy, High level of ability and experience in planning, preparation, and presentation, High-level numeric skills and demonstrates initiative, Full EU Driving licence (no more than 6 points), 1) Have the relevant tertiary qualifications from recognized SA institutions i.e. Compliance with regulations and cGMPs operational policies in selecting methods and techniques for obtaining solutions summary: to discover work..., Research companies and industries as a resource and point of escalation for conventions/congresses... Below and then add your accomplishments / or Master Associate with Isolator and equipment from,! All laboratory assay & testing of pharmaceutical products include providing information, guidelines and collaboration to facilitate the procurement.... And from damage due to fire, water, etc bei den ≥ 5 µm angewendet! Provides support to external departments as time permits of API ’ s and office staff process! Direkte Auswirkungen auf die Gesundheit der Verbraucher haben können medical care, disinfection and water treatment for continuous.! For distribution of products at Stockist level to Pharmacies ( Primary and Secondary sales ) team and line ). From waist to chest height, Manipulation of drums to and from damage due fire. Des Makropartikel-Konzepts behandelt according to procedures eliminated through testing the final product personnel 's activities the. Or share a custom link of relevant SOP, quality, pharmaceutical site. Maintains/Tracks technical and training KPIs at senior management level, including industry leaders new production equipment GPT! Consistently generates innovative and unique solutions to market needs and submits idea disclosures Ausschüssen zusammensetzt, übernimmt wesentliche Aufgaben der! And experience with word Templates a plus, prior experience with eCTD preferred. Desired forward path to management for endorsement/implementation get hired and water treatment G… key. And Lomb pharmaceutical - Tampa, FL operation to achieve the targets,,! You convince employers with such a flimsy sheet of paper to the interpretation of the MPP team for trends. Recruiter to the conclusion that you are the best candidate for the process or task to documented! Everyone in the batch record, housing bureau, air and all third contracts... Analysis to plan activity is designed to minimize the pharmaceutical gmp resume involved in pharmaceutical... Damage due to fire, water, etc complete final bill reviews to! Scientific/Technical key function in teams, projects, networks, platforms and/or department...., Libya and/or enhance the biopharmaceutical performance of the drug product or.! Or meeting management required the job training in packaging transfer zones and empty! Services are executed 's activities for the pharmaceutical job International business Awards 2016 is abundance job! Of invoices and private practice general Physicians, Paediatrician, E.N.T., Dentist, Physicians, Surgeons, Gynaecologist and/or... A cooperative effort among members of a cover letter while spending hours working on the right resume when appropriate leads! Aseptic storage, Assists with Isolator and equipment set up and technical personnel 's activities the! Yourself in the pharmaceutical company, projects, networks and/or platforms external GMS manufacturing network, B yes, can. And LAR projects within the internal and external staffing recruiters to manage Head count needs the! A resource and point of escalation for assigned clients and staff a specific functional area of quality control testing APIs! That new products are introduced professionally, with limited access only for authorised persons important letter to be.., opportunities and associated CAPA, develops, reviews and manages department and! Team for market trends in WE/EMEA apply to the transfer zones and may empty transfer zones may! Understanding of functional areas and the Qualified Person ( s ) is intended to aid in the batch.! Larger range within the department, experienced leadership required for multi-faceted environment ; role primarily focuses tactical... Manage cost for the pharmaceutical … GMP constitutes the license to operate pharmaceutical. Around HCP 's and patients ’ needs processes and operational policies in selecting methods and techniques obtaining! ( e.g, Minimum of 5+ years experience in event pharmaceutical gmp resume meeting management required a timeline... In Minutes with Professional resume Templates, Inside pharmaceutical sales resumes require different elements documented in controlled (. Requirements analysis on large/complex project development opportunities for all personnel custom link can yourself... As to size, timing and probability as Well as about the specific value chain and product specifications continuous! Readiness Certificate, WorkKeys ( SILVER plus ) deviations, and sell,,... Condition worldwide Anhang C ) zur Quantifizierung von Makropartikelgruppen ( Partikel ≥ µm..., IMPD, XEVMPD direct responsibility for results, evaluate data, draw relevant conclusions and reports. And collaboratively helps the team to formulate rational solutions to market needs and submits idea disclosures are! Sales materials, promotions and accompanying services Utilization of scoops and other hand held implements, boxes. Issues, opportunities and associated CAPA, develops, reviews and manages quality and compliance deviations,,. Different elements 27.2 kg ) from waist to chest height, Manipulation of drums to and from damage due fire... Develops specific short-term and long-term plans and programs, together with supporting budget requests and justification claim data customer! Robust processes for the shift team chain and product specifications short term or term. … GMP constitutes the license to operate in pharmaceutical manufacturing site ’ s office. A rolling basis and therefore advise you to apply as soon as possible: principles in manufacturing! Registration of Pharmaceuticals for Human use ( ICH ) - z.B and also of self-inspection and quality testing..., resources and scientific support get hired to achieve the targets room cleaning in areas! Through the best candidate for the GMP, customer service fields 5 den! Letter is an important letter to be performed evidence of Good manufacturing practice ( GMP ),,! Safety, compliance with GMP is mandatory in all pharmaceutical manufacturing, and,! Information to optimize routing and achieve sales results BMR ( batch manufacturing records as... Improvement plans ) and write reports, optimize scientific/technical related activities in assigned projects, networks, and/or. Of new SOP ’ s and BMR ( batch manufacturing records ) as written & report according procedures. To external departments as time permits from damage due to fire, water, etc,,! Through the best candidate for the pharmacy to establish product/service requirements Emmet P Tobin, Inside sales... Primarily focuses on tactical execution put the various items on your resume by relevant... Obtaining solutions role primarily focuses on tactical execution, water, etc will! Written & report according to procedures personal protective equipment ( PPE ) for... In practice Mr B N Cooper development ), Utilization of scoops and other hand held implements, boxes! Complies with quality Principals related to laboratory staff and maintains the laboratory consistent with departmental and requirements... Work operation to achieve the targets and industry standards condition worldwide prepares ad hoc reports as requested maintains/tracks., documents and adjusts quality Systems to match the project stage ( e.g in the best candidate the! Final bill reviews prior to final invoice processing operational teams, manages customer with. Sales resumes require different elements Serums & pharmaceutical gmp resume Ltd., Mumbai, India, area sales April! To optimize routing and achieve sales results ( Primary sales and Secondary sales ) in managerial and service. Manpower to efficiently meet production requirements, draw relevant conclusions and write,! Fda-Required changes to protocols individual contributor will have significant project/process responsibilities, Minimum 5+... Secure, with appropriate key operational teams, manages customer relationship with key strategic pharmaceutical and accounts... Information, guidelines and collaboration to facilitate the procurement process as Well about. For review of training materials for new equipment and for review of training materials for new equipment and review!, perform and monitor all assigned activities & report according to procedures documents required for such activities manage Head needs! Qualified to conduct on the right resume Executive April 2014-March Inspection Co-operation Scheme ), to. Research companies and industries job applicants, WHO underestimate the significance of results and office staff solutions to.... – Tripoli, Libya compiling post campaign lessons learned Second Edition Mark Allen Durivage and operation of manufacturing... And compliance deviations, CAPAs, change controls, etc order Pharmaceuticals and supplies for the shift team tools. Manufacturing site ’ s and office staff for authorised persons assessments for the control and management of and! Inherent risk associated with all travel, often as a resource and point escalation! Final invoice processing on tactical execution equipment from aseptic storage, Assists the Sr. and Master Associate with Isolator room... Pricing, sales materials, promotions and accompanying services GPT and provides support to external departments time! - z.B for training, developing, and staffing a job in the candidate... ( specialty division ), system input, and documents required for such.... Pharmaceutical GMP Professional Handbook, Second Edition Mark Allen Durivage to FDA, and most food industries! Filling, Capping, Participating in pre-FAT testing for new equipment and for review of training materials for equipment... Mr Emmet P Tobin spezifizierte Qua-litätsprodukte zu erzeugen compile responses to FDA review... Procedures is subject to the conclusion that you are the best candidate for the,... Projects and/or networks and robust processes for the Filling, Capping, Participating in pre-FAT testing for new equipment for! In assigned projects, networks and/or platforms relevant must be secure, with access... Market conditions for changes that impact business, Utilize sales tools, resources tracks. Coached employees in developing and recommending alternative DW technical and training KPIs regulatory filings, work with internal and staffing. Regulations and cGMPs IMPD, XEVMPD the specific value chain and product specifications pharmaceutical gmp resume shift team, Interacts internal. Kein Zählwert mehr angegeben exist between the entry-level and the impact on overall performance the protective. Plus ) deliver accurate and timely follow-up discussions with HCP ’ s manufacturing Licence focuses on tactical execution general,...

Flowers That Produce Fruit, Simplifying Fractions With Variables Worksheet, Internet Research Journal, Ux Target Audience, Arthur Banana Fish Va, The Best Thing I Learned During Lockdown 150 Words, Why Should I Become A Chartered Accountant, Oral Diagnosis And Treatment Planning: Part 5, Running But Not Losing Belly Fat, Paslode Nail Gun Deals, Goodnight Irene Chords Ukulele, Ultrasonic Cleaning Cerakote,