Roles & Responsibility

- Perform and review Equipment Qualification activities (IQ, OQ, PQ).
- Manage and monitor HVAC qualification and validation activities.
- Handle Stability Studies and ensure compliance with regulatory requirements.
- Execute Installation Qualification and Temperature Mapping for storage areas and equipment.
- Perform Process Validation and prepare validation protocols and reports.
- Prepare, review, and maintain Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
- Conduct Laboratory QA (Lab QA) activities and ensure compliance with GMP/GLP requirements.
- Review and investigate Laboratory Investigations (Lab Investigations), including OOS, OOT, deviations, and CAPA.
- Participate in internal and external audits, ensuring audit readiness and timely closure of observations.




- Perform Empower data review and ensure data integrity in accordance with regulatory guidelines.
- Ensure compliance with cGMP, SOPs, and applicable regulatory standards.

Preferred Candidate Profile

The ideal candidate should have hands-on experience and sound knowledge of:

- Equipment Qualification (IQ/OQ/PQ)
- HVAC Qualification
- Stability Studies
- Installation Qualification
- Temperature Mapping
- Process Validation
- Preparation and review of BMR & BPR
- Laboratory Quality Assurance (Lab QA)
- Laboratory Investigation (OOS/OOT, Deviations, CAPA)
- Audit preparation, participation, and compliance
- Empower software review and data integrity practices
- Positive Manufacturing Practices (cGMP) and regulatory requirements

📌 Quality Assurance-Executive, Senior Executive and Deputy Manager. (Pithampur)
🏢 Piramal Pharma
📍 Pithampur