Job Location: Bengaluru, Karnataka, India On-site 

Key Responsibilities:

• 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.

Desired Profile:

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

Quality Assurance Manager- API | Biocon | LinkedIn