Senior Executive - IPQA

Piramal Pharma Ltd

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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 - IPQA

Job Description

Responsible for ensuring compliance with GMP (Good Manufacturing Practices) and quality systems throughout manufacturing operations. The role involves batch documentation review, in-process quality assurance activities, sample management, vendor qualification support, validation activities, document control, and coordination for product release.

  • Line clearance for production operations.
  • Review of BMR, BFR, BPR.
  • In - process QA functions.
  • Control sample management.
  • Collection of In process / Finished product and customer samples.
  • Compilation of APQR data with trend analysis.
  • Participation in process validation, hold time studies etc.
  • Co-ordination for batch release.
  • Routine GMP verification in production and warehouse, production and all other departments.
  • Co-ordination and review of vendor management documents, compilation of vendor assessment reports.
  • Document Archival management as on when required.

Issuance and control Formats, SOPs, Specifications and Batch Records.

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