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The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.
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Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory. Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
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Bachelor's degree in relevant engineering or science discipline (chemical/mechanical /bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required.
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PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development. Bachelor's degree in Pharmaceutical Science or a related scientific field with at least 15 years of experience in pharmaceutical formulation and product development.
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Must be familiar with cGMP/GLP practices for analytical laboratories, and with ICH and FDA guidance. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health.
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Understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
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Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines). Equipment Maintenance and Repair: Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
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They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries. A strong understanding of cGMP/GLP requirements and QA procedures for an analytical laboratory.
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A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
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Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment. Knowledge of cGMP in the pharmaceutical industry. Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
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Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
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Bachelors degree in Engineering, Packaging or related science field and minimum 5 years package engineering, package development and/or technical support of existing packages in the pharmaceutical, biotechnology or related cGMP regulated environment.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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DOWNLOAD OUR CODE OF CONDUCT The Laboratory Information Systems Specialist is person with pharmaceutical chemist experience, will act as SME, and will play a key role in the implementation of LIMS other laboratory system.
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Maintain the laboratories with good housekeeping practices and in compliant with cGMP. · Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment. Bachelor’s degree in Chemistry or related scientific field and 2+ years related experience in pharmaceutical analysis OR Master’s degree in Chemistry or related scientific field and 1+ year related experience in pharmaceutical analysis.
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pharmaceutical cgmp jobs in New Brunswick, NJ
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