Manager Quality Assurance

3 weeks ago


Mumbai, Maharashtra, India Abbott Laboratories Full time

Job Responsibilities :

Accountable for following activities of Contract Operations Quality:

  • Well acquainted with QRM process and should able to independently perform the QRM assessment.
  • Capable to handle multiple projects and well versed with project management skills
  • Should have good communications, drafting and presentations skills.
  • Well versed with Excel/ PowerPoint applications.
  • Well versed with Schedule M/WHO/ D&C acts /cGMP/GLP/CDSCO guidance's and should able to ensure compliance at TPM sites.
  • Perform TPM site visits on scheduled basis to ensure continuous Quality compliance.
  • Well versed with Pharmacopoeia changes and compliance.
  • Should able to conduct investigation of the Market complaint, root cause analysis, CAPA implementation and its effectiveness check.
  • Review, assessment and approval of change controls, deviations, OOS/Failures.
  • To perform technical assessment of change control, audit CAPA tasks in QMS system.
  • Should have ability to impart technical training to quality and operations staff.
  • To perform assessment of new site for cGMP compliance as and when required.
  • To carry out TPM performance monitoring by reviewing the metrics and score card as defined in the procedure.

Minimum Education

B.Sc / M.Sc /B.Pharm / M.Pharm

Minimum Experience / Training Required :

At least 10 – 15 years of relevant experience in quality assurance function either at internal sites / third party manufacturers. Incumbent having expertise in Quality Risk Management, Quality Project Management will be an preferred.



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