Manager IPQA

Description

JOB DESCRIPTION

Essential Functions

• To ensure GMP practices at manufacturing shop floor.
• Responsible to ensure the compliance in all the functions like warehouse, manufacturing, and packaging area.
• Responsible for Quality Compliance at Shop floor. Overall responsible for IPQA Activities in Mfg, Packaging and Warehouse.
• Review of Master documents, Batch Release. Responsible for monitoring of IPQA activities like line clearance, printed packing material dispensing, RM dispensing verification and calibration of IPQA instruments.
• To ensure proper sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids.
• To ensure in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents by IPQA team and responsible for calibration of IPQA instruments.
• To ensure archival of executed documents like BMR, BPR, Hold time Protocol etc..
• To ensure preparation and review of CPV data trend.
• To perform impact assessment of maintenance intimation form.
• To ensure timely review of executed batch records/protocols.
• To initiate change control, unplanned, planned deviation and CAPA wherever required.
• System up-gradation as per cGMP compliance in manufacturing, packaging, & warehouse area.
• Responsible for review of calibration records and executed Batch Manufacturing and packaging Records and respective electronic records.
• Responsible for review and approve packaging artworks, proofs, and shade cards.
• To review and approve the quality Notification (Viz Change control, Deviation and OOS) during Batch Manufacturing/packaging and to prepare and review MSP protocols wherever required.
• Responsible for monitoring of environmental condition of label control room.
• To prepare, revise and review functional SOPs, wherever required.
• To perform the batch release for commercial and filling purpose.
• To review and approve master protocol, PSR,BMR, BPR, SOPs, BOPM, annexure for specimen, exhibit batch readiness checklist and other GxP documents.
  
  

• To ensure timely training of IPQA personnel on assigned SOPs.
• Responsible to ensure all the quality issues are handled as per respective SOPs, investigated to identify the root cause /most probable root causes and appropriate CAPA is initiated to avoid recurrence of the quality issue and take appropriate immediate action if required.
• Responsible to ensure all the quality issues are handled as per respective SOPs, investigated to identify the root cause /most probable root causes and appropriate CAPA is initiated to avoid recurrence of the quality issue and take appropriate immediate action if required.
• Participates in the quality Operations management to achieve effective and efficient operation and Organization goals.
• Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.
  
  

• Bachelors Degree (BA/BS) B. Pharma - Preferred
• Master Degree (MS/MA) M. Pharma - Preferred
  
  

• 12 years or more in 12-14 years