Strides Pharma looking for IPQA Lead - B.Pharm, M.Pharm Apply

Incorporated in 1990, Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bangalore, India. The Company has two business verticals, viz., Regulated Markets and Emerging Markets. Strides has a global manufacturing footprint with eight manufacturing facilities spread across four continents, including five US FDA approved facilities and two facilities for the rest of world markets. The Company has a dedicated R&D facility in India with global filing capabilities and a strong footprint across 100 countries.

Post : Lead-IPQA (OSD)

Qualification : B.Pharm/M.Pharm
Experience : 12-15 Years
Location : Chennai

Job Description
- Operational Quality assurance in Tablet & HGC manufacturing.
- Review and approval of WI/SOP’s and formats related to production operation.
- IPQA shift planning and coordination based on the production requirements.
- Ensure In-process, Semi finished, Finished and Control samples are collected, handled and stored as per cGMP requirements.
- Ensure timely review and / approval of executed batch records; and final batch release to market and disposition (Release/Rejection) of in-process and finished product batches as appropriate.
- Review and ensure continuous cGMP compliances in shop floor.
- Ensure Raw material samples are collected, handled as per cGMP requirements.
- Plan and monitor required training and development, motivate team appropriately in order to ensure a committed, motivated and competent team.
- Take the lead for evaluation, review and approval of all QMS related to Manufacturing and Packing
- Well verse with Trackwise, SAP, LIMS
- Having Exposure of Audits (USFDA, MHRA, Health Canada)