David Hubert
- Role
- Qa Associate Director at BA Sciences
- Location
- Winchester, MA, US
- LinkedIn followers
- 500 followers
About David Hubert
Sr. Compliance Specialist, Quality Assurance; Merrimack Pharmaceuticals One year + of…
Experience
Qa Associate Director
Jul 2018 — Present
Implementing and maintaining Quality systems and procedures in compliance with all current FDA GMP regulations and guidance, as well as relevant ICH guidelines. Manage quality operations and compliance functions, provide expertise and direction in relation to quality initiatives.
Skills
- Pharmaceutical Industry
- Quality System
- Gcp
- Quality Control
- Clinical Trials
- Regulatory Affairs
- Gmp
- U.s. Food and Drug Administration (Fda)
- Glp
- Laboratory
- Aseptic Processing
- Lims
- Fda
- Sop
- Gxp
- Change Control
- Life Sciences
- Capa
- Management
- Laboratory Information Management System (Lims)
- Software Documentation
- Quality Assurance
- Regulatory Submissions
- Biopharmaceuticals
- U.s. Title 21 Cfr Part 11 Regulation
- Standard Operating Procedure (Sop)
- Corrective and Preventive Action (Capa)
- Lifesciences
- 21 Cfr Part 11
- Biotechnology
- Validation
- Good Laboratory Practice (Glp)
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