Sr. Executive - QA (IPQA GI)

Role & responsibilities :

• Responsible for review and execution of SOP, Master BMR and BPR, Qualification document and Validation Document.
• Responsible for review and approve the Master BMR/MPR, Executed BMR/BPR and batch release on behalf of section head.
• Responsible for monitoring, verification and review of all IPQA activities on shop floor of Injectable Department
• To ensure the cGMP compliance in the shop floor area i.e. manufacturing. Warehouse, packing area.
• To participate in the assessment and review of Change control, CAPA, Risk assessment related to shop floor.
• To participate in the investigation of the Deviation, Market complaint and OOS related to shop floor.
• To prepare the QA SOPs and IPQA related Documents.
• To Carry out in process checks and line clearance activity during each stage of Manufacturing and Packing.
• To carry out Collection and monitor of in-process sample, Finished Sample, Stability sample, Retain sample and other samples throughout manufacturing and packing of injectable products.
• To participate and execution in the Media Fill activities and prepare/review the media fill protocol/reports.
• Responsible for sampling during Process validation and Cleaning Validation.
• Preparation and Review of Deviation, Change control, Market Complaint and CAPA of respective shop floor area.
• To ensure Qualification, Calibration and Preventive maintenance of all equipment and instrument are validated stage.
• To give quality observation for any non-compliance of GMP Practices and Trending the Observation of BMR, BPR, and Quality Observation.
• To review the audit trail reports and printouts generated during operation.
• To perform all the tasks assigned by the senior or reporting authority.
• To approved/authorized GMP document in absence of department superior.

Preferred candidate profile : The Candidate must have experience in IPQA in injectable plant OF minimum 7 years.