Senior Manager Quality Assurance | Sun Pharma | Halol

Job Description

Senior Manager Quality Assurance

Job Responsibilities:

• Parenteral GMP documents review and approval.
• Review of Validation protocol and report
• Media Fill records review and Approval
• Internal Quality Observation handling and review/ approval of quarterly/yearly trend report
• To review of study protocol, other activity protocol
• Breakdown memo handling
• Equipment and area cleaning/sanitization logbooks review
• Verification/ Approval of Access level rights
• Review/ Approval of Sterility Assurance and EMS data
• Review/ Approval of area qualification activity
• Management and review of smoke study activities
• Review of Risk assessment/Impact assessment of process
• Support during the execution of Equipment qualification and validation-related activities like Process validation, Cleaning validation, and characterization batches
• Ensure procedures for sample collection/transfer (completion of test request) as per approved batch record or protocol
• Review of CPV protocols and Trend the data in Minitab
• Reporting of deviation/audit observation
• Review of documents through EDMS.
• Review of Deviation Investigation and Change Control in the TrackWise system
• Support Internal / External Audits/ Inspections and review their response/ corrective actions, as applicable
• Ensure Line clearance, Equipment clearance and Start up clearance
• Ensure procedures for finished product sample collection and Batch release
• Ensure Log book/Protocol/ Water trial/Extra page issuance and retrieval as per SOP requirements
• Supporting operations in assisting or providing and documenting training when required
• Ensure Compliance of Line clearance at the warehouse for Dispensing activity
• Sign / Approval of cGMP documents as QA Head designee as and when required

Educational Qualification – B.Sc in Microbiology, B.Pharma, MS/M.Sc(Science) in Biotechnology, Microbiology, M.Pharma

Experience – 10 to 15 Yrs

Location – Halol