Role - QA Lead
Location - Bangalore
Industry - Pharmaceutical Industry
Required Experience - Minimum 16 years - Max 24 years
Qualification - M.Pharma
Responsibilities : -
- Will lead all internationl regulatory audits – USFDA, EMA, MHRA, ANVISA, ROW.
- Will lead the site operations with vast process understating of Pharma products of all dosage forms.
- Will conduct Vendors, external laboratories, external service audits and compliance is verified.
- Review and approval of Master formula records (MFR’s), Batch manufacturing & packing records.
- T raining of team, & CFT teams on Good manufacturing practices, Data Integrity, Good laboratory practices.
- Review and approval of stability Protocols & reports
Brief Requirements :
Should have worked on the shop floor and have sound process knowledge in manufacturing Semisolid, Solid oral, Liquids & powder dosage forms.Should have a thorough understanding of GMP guidelines and regulations applicable to Pharma products.Should have sound knowledge of Unit operations & Process equipment’s.Should be well versed with ERP systems like S AP, LIMS, DMS, QMS, etc.Should have detailed process understanding and should have handled team directly.Candidates from the Pharmaceutical industry with experience in the above mentioned responsiblities are invited to apply to this role by sending in their applications to poornima.c@classicsearchplc.com