The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance.
Requirements
- 5+ years of experience in Quality and/or Validation.
- 7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred.
- In-depth knowledge of cGMPs, technical writing, data management collection, and analysis.
Responsibilities
- Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment.
- Provide strategic quality oversight of facility and equipment commissioning and other activities.
- Review and approve: Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports.
- Review and approve: Validation related deviations and discrepancies.
- Review and approve: Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports.
- Lead QA support for risk assessment, FMEA, and change controls governing validation related activity.
- Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations.
Other
- Standard (Mon-Fri)
- Office
- The role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions.
- Develop and maintain a safety and quality culture.
- Mentor and train junior QAV Engineers.
