Job Location: Bengaluru, Karnataka, India On-site
- Approval of Master Batch Manufacturing Records, Packing and Dispatch Records, Standard Operating Procedures, Equipment Cleaning Checklist, Equipment Operating Procedures and Checklists.
- Planning and scheduling of team activities.
- Routine oversight of training management/Document/records management/Warehouse management.
- Implementation of company quality policies and GMP regulations.
- Approval of Quality Department documents like protocols, reports, Standard Operating Procedures.
- Approval of Annual Product Quality Reports.
- Facilitate review of APQRs for common products manufactured at applicable sites.
- Review and approval of Customer Assessment questionnaires and their queries.
- Handling of SAP software activities related to batch release, dispatch, Raw materials and Warehouse Management System and material destruction.
- Reporting to management on the performance of Quality systems for any needs for its improvement.
- Approval of master BMR template in Bizapp software.
- Review and approval of quality agreements.
- Handling of Inter Unit Transfer of materials.
- Preparation and assigning of roles to team in SAP SF Learning Management software.
- Approval of Standard Operating Procedures (SOPs), Equipment Operating Procedures (EOPs), Operation Control Procedures (OCPs), Standard Cleaning Procedures (SCPs) through File Net Software.
- Issue of Annexures, Checklists and Logbooks.
- Release of BMRs for batch release or rejection.
- Review and approval of Process validation / Cleaning validation / Cleaning verification/
- Qualification/Study Protocols and reports (As applicable).
- Review and approval of Site Master File.
- Review and approval of Quality Manual and Master validation planner
- Handling of (Internal Audits / Customer Audits /Regulatory Inspections) and facilitate compliance of associated CAPA (if any).
- Recruitment of personnel to Quality Assurance department.
- Oversight of routine manufacturing functions.
- Review/ Approval of transport /Shipping validation.
- Review/ Approval of Customer returns and product recalls.
- Handling of SAP transactions.
- Assist regulatory science department for product filings.
- To support queries from marketing and SCM functions on product quality and business requirements.
- Review of pest control documents.
- On time completion of assigned trainings.
- Review and approval of floating formats (Schedule/Planner/Annexures/Registers).
- Review/Approval of stability tracker & stability inception planner.
- Review of various certificates provided by external agencies.
- Conduct training to relevant functions.
- Provide assistance for support of QMS activities (Out Of Specification, Out Of Trend, Deviations, Change control, customer complaints, customer returns, Corrective Action and Preventive Actions and Risk assessments).
- Coordination for change in dispatch plans.
- Handling of Error rectification.
- Verification and approval of specimen signatures.
Ideal candidate should be M.Sc in Chemistry with minimum 15 years of experience in Process / Manufacturing QA from a API industry with good exposure to audits.
How to Apply?
Apply through following link