Senior Executive, QMS (QA)
Summary
Oversee a pharmaceutical company’s Quality Management System, ensuring cGMP compliance by handling deviations, CAPAs, complaints, and audits.
Description:
- Managing overall activity of QMS. Establishing and implementing quality systems to comply cGMP. Handling of Product Complaint, Deviation, OOS (Out of Specification), OOT (Out of Trend), Incident and Change Control.
- CAPA management, tracking, verification of implemented CAPA from CCN, Deviation, OOS, Self-Inspection and Market complaint.
- Review of SOPs, Instrument operating procedure, standard test procedure, effective implementation of SOP.
- Handling of Self-Inspection.
- Annual Product Quality Review (APQR/APR) preparation and review, trending of quality parameter.
- Handling of Recall and Investigation of the same.
- Develop and execute risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups.
- Vendor Qualification: Handling the Vendor Qualification and Re-approval audit for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary Packaging Material), Contract analysis laboratory and Contract services
Education: B. Pharm / M. Pharm
Experience: 5 - 8 Years
Note: Interested candidates who wants to apply for internal job posting must have completed minimum 2 years in their existing job role.