Executive IPQA

• Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. 
• Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. 
• Responsible for review of executed BMRs and BPRs.
• Responsible to perform the in-process test at different stages as per batch document/SOP. 
• Responsible to review the different type of planner and calibration certificates. 
• Responsible to monitor cGMP compliance at shop floor. 
• Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. 
• To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. 
• Responsible to participate in media fill simulation study. 
• Responsible to participate in perform qualification activities of manufacturing area. 
• Review of Media fill CD. Review of Visual inspector qualification record.

Skills:

• In-Process Quality Controls (IPQC) & Sampling - Practitioner
• Aseptic Process Simulation (Media Fill) Monitoring - Expert
• Line Clearance & Batch Record Review - Practitioner
• Good Documentation Practices (GDP) - Practitioner
• Regulatory & Compliance Knowledge - Practitioner

Qualifications

Education: B.Sc./ M.Sc/ B.Pharma / M.Pharma

Total Experience - 1 - 6 Year inexperience in IPQA / Environmental Monitoring for sterile manufacturing plant

Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.