ASSISTANT MANAGER

Biocon

  • India
  • Permanent
  • Full-time
  • 6 days ago
Department DetailsRole SummaryIPQA (Manufacturing compliance)Key ResponsibilitiesHandling of QMS documents (Change control, Deviation, OOS, OOT, Market complaints, Returns, Recall, Risk Management, change in Dispatch plan, ERRATA and CAPA etc.) ·
Initiation / Login of Quality Management System an classification (Change control, Deviation, . · Provision of site acceptance for change control as per need basis.
Preparation, review and approval of quality documents (SOPs, planner, schedule etc.) · Handling of Investigations for Quality Management System · Review of QMS for routine batch release or rejection. ·
preparation and Review of Process validation/Study - Protocol and Reports. · preparation and Review of cleaning validation - Protocol, Establishment of Swab and Rinse limits reports, MACO calculations and Validation reports.
Preparation, Review and approval of Annual Product Quality Reports annexures. · Handling of Customer audits/ Regulatory Inspections/ Internal Audits (Self inspection and Corporate Audits).
Perform trend analysis of Quality Management System Parameters.
Preparation, Review and Approval of Risk Assessment protocol, FMEA and reports.
Coordinating with cross function team members for achieving quality requirements:
carrying out internal GMP rounds report / inspection outcome and review of action plan. Preparation Review and approval of Quality Documents and procedures.Educational QualificationsRequired Education Qualification: B.Pharma
Required Experience: 5 - 7 years

Biocon