
Operations Director: Compliance Officer
1 week ago
We are seeking a seasoned Quality Assurance Manager to lead our Vendor Qualification and Management team. The successful candidate will be responsible for ensuring compliance with current Good Manufacturing Practice (cGMP) regulations.
The ideal candidate will have excellent leadership skills, the ability to communicate effectively with vendors and internal stakeholders, and a strong understanding of quality management principles.
- To ensure cGMP compliance at site.
- Responsible for Vendor Qualification and Management.
- Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status.
- To review vendor documents for Vendor Qualification.
- To perform the Vendor audit and its compliance for RM/PM.
- To prepare Vendor Audit Report and confirm the compliance.
- To Review and Approve the Approved Vendor List of RM/PM.
- To Review/Approve Annual vendor audit Planner/Scheduler.
- To receive the pre-purchase samples through Purchase Team and send it to QC/ARD for further assessment.
- To review the Pre-purchase analyzed report and take necessary action as applicable.
- To participate in investigation/QRM related to vendor of RM/PM
- Follow-up with vendor regarding CAPA
- Bachelor's degree in Life Sciences or related field.
- Minimum 3 years of experience in Quality Assurance or related field.
- Strong understanding of cGMP regulations and guidelines.
- Excellent leadership and communication skills.
We offer a competitive salary package, comprehensive benefits, and opportunities for professional growth and development.
OthersThis role requires strong analytical and problem-solving skills, attention to detail, and the ability to work effectively in a fast-paced environment.
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