Quality Assurance Lead

Role - QA Lead

Location - Bangalore

Industry - Pharmaceutical Industry

Required Experience - Minimum 16 years - Max 24 years

Qualification - M.Pharma

Responsibilities :-

1. Will lead all internationl regulatory audits – USFDA, EMA, MHRA, ANVISA, ROW.

2. Will lead the

   site operations

   with vast process understating of Pharma products of all dosage forms.
3. Will conduct Vendors, external laboratories, external service audits and compliance is verified.
4. Review and approval of

   Master formula records (MFR’s), Batch manufacturing

   & packing records.
5. T

   raining of team, & CFT teams

   on Good manufacturing practices, Data Integrity, Good laboratory practices.
6. 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