Looking for Successful Leaders
The incumbent will assist and support the QA Director in establishing and maintaining Tedor’s Quality Systems. This individual will coordinate pharmaceutical quality system activities for the review, approval and disposition of drug product for use in clinical trials and commercial settings. This individual will lead and support all investigation/CAPA activities related to product release, including conducting and preparing the investigation reports, coordinating the execution of corrective and preventative actions and affiliated change controls, and conducting CAPA effectiveness checks.
- Coordinate the review, approval and disposition drug products for commercial and clinical releases.
- Review & approve batch records for pharmaceutical solid oral dose products (both commercial and R&D).
- Interact with contract packaging sites to monitor and assure pharmaceutical quality system adherence.
- Facilitate and lead cross functional teams in investigations of deviations, nonconformances, CAPAs, and product complaints to determine root cause and implement corrective actions to mitigate root causes; work constructively with functional groups to determine root causes for process issues related to products and services.
- Manage and track Deviations, CAPAs, Change Controls, and works with departments to ensure on-time completion.
- Write, review and approve specifications, standard operating procedures, test methods, stability and process protocols and test results.
- Create metrics and trend data
- Support, improve, and maintain the Quality Management System (QMS)
- Ensures compliance with company’s procedures and regulatory requirements.
- Participate in internal/external audits and supports inspection readiness
- Drive activities for the development, review, and approval of Annual Product Review (APR) reports
- Initiate, revise and Review and approve Policies, SOPs, Work Instructions, Forms, and Templates, or other controlled documentation.
- Performs other QA duties as assigned.
- Achievement Orientation
- Organizational Orientation
- Teamwork and Cooperation
B.S. / M.S in Pharmacy/Chemistry/ Biochemistry or relevant field with 5 – 8 years QA CAPA and Change Control experience in pharmaceutical environment. Familiarity with USP/NF compendia and FDA guidance for method validation and transfer, process and cleaning validation. Previous supervisory experience is a plus. Detailed knowledge of pharmaceutical quality manufacturing, packaging, and material handling, thorough knowledge of 21 CFR Parts 210, 211 and related guidance. Excellent writing and communication skills. Proficiency in MS Excel, PowerPoint and Word is essential.