Manager QA

India Pharma People
  • Mumbai
  • Confidential
  • 10-17 years
  • 12 Aug 2015

  • Production/ Manufacturing/ Engineering

  • Bio - Tech, Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Overall responsibility of Quality Assurance Department.
To ensure compliance with the statutory requirements a

Approval of Specifications, Master Formula Records, SOPs and Batch manufacturing records.

To ensure compliance of qualification & calibration of instruments / equipments.

To ensure validation of analytical methods, manufacturing /cleaning processes & utility systems.

To prepare training schedule and ensure training of personnel as per schedule.

Review and Approve Packaging material artwork.

To conduct vendor audits of raw / packaging materials vendors & contract laboratories.

To conduct or ensure self-inspection of the plant is carried out as per Schedule.

To co-ordinate with Stores, Production Department and Packing Department for quality improvements.

To ensure preparation, maintenance, distribution & control of MFRs, BMRs, BPRs, SOPs.

To review stability/ reports and validation documents and take appropriate actions.

To investigate Out-Of-Specification and review & approve deviations/change controls & CAPA.
Handling of Market complaints.

Responsible for product recall at site.

Up gradation of Site Master file, all other Quality system manuals & related documents.

Coordination with R & D for approval of vendors for raw & packaging materials.

To plan & conduct internal audit of different department as per schedule

To handle regulatory inspection & other country specific audits.

To ensure effective document control process and archival of GMP related documents.

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India Pharma People