Bachelor of Science in Chemistry, Biochemistry, Industrial Pharmacy or related scientific field, or foreign equivalent degree, or comparable level of technical training through formal education and/or industrial experience.
2 – 5 years’ experience in a cGMP quality, regulatory, and/or chemical manufacturing environment, with applied knowledge of GMP principles across quality disciplines, including but not limited to: Change Control; Training; Investigations; CAPA; Supplier Qualification; ICH stability studies; Method and/or Process Validation.
Advanced demonstrated knowledge and proficiency in at least one of the following aspects of pharmaceutical operations:
Analytical services, including equipment operation, laboratory data review, and material testing technologies (e.g. HPLC, GC, FTIR, KF, UV, TOC, wet chemistry)
Manufacturing, including batch processing, equipment maintenance and calibration, batch record review
Proactively perform Quality Assurance function in full compliance with current Good Manufacturing Practices applying regulations ICH Q7 and 21 CFR 211.
Consistent contribution to daily Quality Assurance operations, including but not limited to the following:
Product release, including data and batch record review
Review, editing and approval of controlled quality documentation
Review of analytical method development and validation
Change control, including documentation, equipment and process changes
Inspection / internal audits of the facility to ensure real-time GMP compliance
Supplier Qualification, including external auditing as needed