Description

JOB 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

Qualifications

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.

📌 Senior Executive, QMS (QA) (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad