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
Corrective and Preventative Action program
Assist QA management in efforts at continuous improvement of the quality program, including but not limited to the following:
Advocate for quality compliance throughout the organization
Periodic review of critical quality systems
Report quality metrics / trending
Take a leadership / ownership role in support of one or more critical quality systems, including but not limited to the following:
Training: develop and perform training opportunities for PCI personnel in critical quality systems, such as LIR, QI and CAPA
Investigations: serve as lead for systemic quality investigations; mentor PCI personnel in growth of investigational skills
Process Validation: serve as PCI subject matter expert for validation of manufacturing, analytical or cleaning processes