Ensuring Uninterrupted Supply of Product and a Responsive Supply Chain for Client patients by maintaining CGMP and regulatory compliance
Requirements
- In depth knowledge of CGMPs and Regulatory Guidelines
- Demonstrated experience performing batch record review and disposition, investigating product complaints and conducting deviation investigations
- Strong knowledge of chemistry or closely related field
- Experience with QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR)
- Familiarity with AQL inspections and sampling
- Understanding of Area Clearance and In Process inspections
- Knowledge of Labeling change controls
Responsibilities
- Provides an independent compliance review of their peer's work prior to final management approval
- Reviews executed commercial production records in a timely manner, ensuring that records are in compliance with GMP's and standard operating procedures
- Conducts, writes and performs risk assessments for investigations/deviations in collaboration with the production unit
- Determines root cause and assigns appropriate CAPA with assistance from the production unit
- Drafts or contributes to QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR)
- Executes AQL inspections and sampling Performs Area Clearance and In Process inspections to support Gliadel production
- Reviews Out Of Calibration report, weekly alarm trends and Labeling change controls
Other
- BS/BA or MS in Chemistry, or closely related field required
- 8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry
- Strong interpersonal and communications skills (oral and written) required
- Demonstrated excellent customer service skills in dealing with external clients
- Critical thinking and effective decision making skills with ability to identify issues requiring further attention
