- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …and Environmental Monitoring sources and solutions; Bulk radioisotopes for pharmaceutical , therapeutic and industrial product manufacturing; Services for collection, ... the guidance of the Director of Quality Operations as necessary, to assure compliance with the company GMP Quality Management System program. Keeps the Director of… more
- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic ... for the Computer System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA , EMA (Annex 1), and other global regulatory… more
- Takeda Pharmaceutical (Social Circle, GA)
- …all fractionation operations comply with corporate policies, regulatory requirements (GMP, FDA , EMEA), and safety practices. The specialist works closely with ... data, and develop presentations and supporting materials as needed. Ensure compliance with all regulatory requirements and internal standards within the… more
- Sanofi (Cambridge, MA)
- …Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from health authorities. ... to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and...least 4 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in… more
- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …routine reporting of equipment and system status, and the reliable supply and compliance of Critical Utilities (HVAC, Purified Water, Clean Compressed Air, etc.) as ... where the gaps are in the Pii Facilities GMP compliance position and make recommendations to the leadership team...engineering and reliability support for all agency audits like FDA , MHRA, and EMA. Maintain all facility drawings of… more
- Inizio Engage (Bernville, PA)
- …how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 ... providers. Anaphylm has the potential to be the first and only FDA -approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic… more
- Sanofi (Morristown, NJ)
- …development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and ... implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to… more
- Sanofi (Morristown, NJ)
- …for submission to regulatory agencies, including but not limited to the FDA and EMA Prepare abstracts, posters and manuscripts for external presentation and/or ... development. Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and… more
- SOFIE (Somerset, KY)
- …clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. Maintain accurate equipment ... Operations and Technical Services, you'll ensure all quality control systems meet strict FDA and cGMP standards (21 CFR 211 and 212). ESSENTIAL DUTIES AND… more
- Takeda Pharmaceutical (Social Circle, GA)
- …regulatory submissions, and made available during internal and external regulatory/ compliance audits. This position will provide interpretation of regulatory ... and evaluate validation documents regarding acceptability to industry standards (GMPs, FDA , EU and JP Guidelines), procedures, and regulatory requirements such as… more
- System One (Cranbury, NJ)
- …compressed air, WFI, and clean steam systems + Solid understanding of cGMP and FDA compliance requirements in Pharmaceutical manufacturing + Proven ability ... Job Title: Maintenance Supervisor - Pharmaceutical Manufacturing Location: Cranbury, NJ Hours / Schedule:...hands-on support, equipment repair and upkeep, facility maintenance, and compliance with cGMP and safety regulations. This role requires… more
- ManpowerGroup (Cary, NC)
- …Integrity, Pride, Accountability, Teamwork, Commitment). + Exposure to diverse instrumentation and pharmaceutical / FDA compliance standards. If this is a role ... excellent customer service. + Identify and report safety issues, ensuring compliance with all safety requirements. + Support project planning, supply readiness,… more
- Cardinal Health (Mansfield, MA)
- …investigations of Out of Specification (OOS) test results as needed follow FDA guidelines. + Maintain compliance with relevant regulatory requirements (eg ... of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing is desired. + Possess a thorough understanding of Good Laboratory… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …including the commercial, medical affairs, regulatory, HEOR, corporate affairs, and compliance teams. Counsel will advise our internal partners through a deep ... communication, advertising and promotion, and strategic brand planning. + Ensuring compliance with all relevant laws, regulations, policies, procedure and controls… more
- Cardinal Health (Mansfield, MA)
- …of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. + Possess a thorough understanding of Good Laboratory Practices ... the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA, Chem Services… more
- Katecho (Des Moines, IA)
- …and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance : Ensure compliance with applicable pharmaceutical regulations ( FDA , ... internal audits. The ideal candidate will have a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance . PRIMARY DUTIES… more
- University of Maryland, Baltimore (Baltimore, MD)
- …invites applications for the position of Chair of the Department of Pharmaceutical Sciences with experience commensurate with the rank of Professor, Tenured. This ... internationally recognized for innovative research and teaching in the field of pharmaceutical sciences and its many disciplines. The Pharmaceutical Sciences… more
- TAI (Rockville, MD)
- …or a related field. + Minimum 10 years of applicable experience with pharmaceutical manufacturing processes and equipment, FDA regulations, and cGMP guidelines. ... **About the Role:** Join TAI as a Pharmaceutical Process Engineer SME to drive critical engineering...of process equipment and process utility systems. + Ensuring compliance with regulatory requirements and quality standards. + Conducting… more
- Lilly (Indianapolis, IN)
- …**Key Objectives/Deliverables:** As AVP-Assistant General Counsel - Head of Global Pharmaceutical Capabilities, you will lead the legal team responsible for ... be to: + Lead and continue to develop a globally focused pharmaceutical commercial capabilities legal team, responsible for counseling on cross-brand and… more
- Katecho (Des Moines, IA)
- …ability and motivation to learn. + Minimum of five years of experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three ... + Preferred minimum of seven years of experience in QA/Regulatory Compliance in the pharmaceutical industry. + Strong knowledge of global regulatory and cGMP… more
