Senior Executive - Quality Assurance

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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title
Senior Executive - Quality Assurance
Job Description
Responsible for ensuring GMP compliance during manufacturing and packing activities through line clearance, in-process checks, and shop-floor monitoring. The role includes review of BMR/BPR, preparation of APQR, sampling activities, review of quality documents, and support for batch release. The position also involves participation in deviations, CAPA, change controls, validation activities, and regulatory audits while coordinating with cross-functional teams to maintain product quality and compliance.
- Perform line clearance for manufacturing and packing activities.
- Conduct in-process checks and ensure GMP compliance.
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and related documents.
- Prepare and review Annual Product Quality Review (APQR) reports.
- Perform sampling as per approved procedures.
- Monitor shop-floor activities and documentation practices.
- Participate in deviation, incident, CAPA, and change control activities.
- Support validation, qualification, and stability studies.
- Conduct routine GMP audits and inspections.
- Coordinate with Production, QC, Warehouse, Engineering, and other departments.
- Support batch disposition and release activities