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Quality Assurance Lead

Quality Assurance Lead

Classic Search Private LimitedMadurai, IN
8 days ago
Job description

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

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    Quality Assurance Lead • Madurai, IN

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