Senior Manager/ Deputy GM - QA

India Pharma People
  • Panaji
  • Confidential
  • 8-10 years
  • 12 Aug 2015

  • R&D/ Research & Development

  • Recruitment/ Staffing
Job Description

Overall responsibility of Quality Assurance Department.
To ensure compliance with the statutory requirements as per Drugs & Cosmetics Act, 1940 and Rules 1945.
cGMP and GLP administrator for Goa Plant.

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

To release finished Product batches for sale & distribution after review of the batch manufacturing records and analytical reports.

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.

Competencies/Skill sets for this job

Packaging Materials Manufacturing Vendors Quality Assurance

Job Posted By

About Organisation

India Pharma People