Officer To Sr. Officer - IPQA at Raks Pharma Pvt Ltd Dahej

Role & responsibilities

• Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations
• To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol
• To Issuance of Bottle label, Ouster and Medication guide for commercial batch
• Oversee the Calibration of IPQA instruments
• Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing areas
• Conduct In-Process Checks and coordinate with IPQC (In-Process Quality Control)
• Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations Current Good Manufacturing Practice for Drugs)
• Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for completeness and accuracy
• Monitor Environmental Monitoring and routine manufacturing area compliance
• Ensure assurance of cleaning, sterilization, and aseptic manipulations
• Perform Sampling of Cleaning Validation and compile records
• Support Process Validation Reports (PVR Process Validation Report) activities
• Participate in Aseptic Process Simulation (Media Fill) monitoring
• Support Change Control & Deviation Management and CAPA (Corrective and Preventive Action) implementation
• Conduct Routine GMP Inspections and review quality records of other departments

Preferred candidate profile

Education

• B. Pharm / B.Sc. / M.Sc.

Experience

• 3 years or more in 3 - 8 Years