Assistant Manager/Manager- Quality Assurance

Role & responsibilities

1. To monitor trainings for all the employees directly associated with all manufacturing activities.

2. To manage overall IPQA, process validation, Lab QA, QA documentation & QMS activity including Change Control, Deviation, CAPA, Lab Incident, OOS, OOT, QRM, Market Complaint, Product Recall, Mock Recall of the plant.

3. The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities. To conduct scheduled audits of external laboratories to ensure compliance with regulatory and quality requirements and timely closure of audit findings.

4. To evaluate batch manufacturing, testing records & processes, systems, procedures.

5. To conduct internal audits for all department in plant and to ensure quality of QMS system in other department. i.e Production, Warehouse, Engineering, QC, HRA and IT.

6. Responsible for The authorization of written procedures and other documents like BMR, BPR, APQR & all QMS documents, including amendments; & compliance of standard operating procedure. To Prepare and Review Cleaning validation Protocol and Report.

7. To handle quality risk management and maintain its record.

8. To execute product recall and mock recall activities.

9. To review and authorization of apex document like SMF, VMP, Quality Policy, Quality Manual, Data integrity policy and finalized all company policies.

10. Training:-To ensure compliance & authorization of training of cGMP (Current Good Manufacturing Practice) practices and GDP (Good Documentation Practices) and Data Integrity.

11. The monitoring of compliance with the requirements of Good Manufacturing Practice

12. Approval of all specifications documents & TDS, STP.(RM,PM,FP), AMT, AMV etc.

13. To audit the vendors as per schedule and ensure audit compliance and its closing. The approval and monitoring of suppliers of materials.

14. To ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.