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Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development.
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We are looking for a Senior Automation Validation Engineer with a minimum of 10 years experience in Delta V with the implementation and validation of Delta V and OSI PI with Instrumentation and Controls in an FDA regulated environment.
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This position directly supervises a team of QA Specialists covering a vast functional area centralizing all aspects of product quality, requiring an abundance of knowledge and established interpretation of FDA Quality Systems Approach to Pharmaceutical cGMP Regulations as well as excellent attention to detail in a rapidly growing business environment.
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Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA preferred. Prior experience as a GMP Maintenance Technician in a complex pharmaceutical or biopharmaceutical manufacturing environment.
$31 - $42 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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A minimum of 10 years of experience in clinical development within the biotechnology or pharmaceutical industry; previous experience in immuno-oncology drug development is preferred. Integrated understanding of FDA, EMA, ICH, and GCP guidelines.
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Knowledge of cGMP manufacturing and GDP. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: HPLC, DSC, KF Titrator, etc. Support laboratory equipment qualification Support test method validation Support laboratory investigation and conduct nonconformance investigation Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
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Requires a basic working knowledge of legal requirements and accreditation standards including The Joint Commission, Title XXII, Department of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), and United States Pharmacopeia (USP.
$93 an hourPart-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
ExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Proven experience in pharmaceutical marketing, with a focus on FDregulated products. Position Overview: As the Marketing Director at Medivant Healthcare, you will play a pivotal role in developing and implementing strategic marketing initiatives to promote our FDA shortlisted drugs to hospitals and clinics.
$120,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
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The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing.
$1,000 - $1,300Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ideally experienced in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes.
$87,100 - $94,600 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
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Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field. The individual in this role will be the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, review and assist in Regulatory filings (ICH/Compendial/FDA and EMA.
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Must have experience in 1 or more of the following: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC) upstream, downstream, purification, recovery, building automation or other pharmaceutical manufacturing processes.
$87,100 - $94,600 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago
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