Assistant Manager / Deputy Manager - IPQA

Description

Essential Functions

• To perform Machine and area clearance during dispensing, manufacturing, and packaging operation.
• To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in process samples and tmanage sampling aids.
• To carry out in process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents.
• Review of Master BMR, SOPs, Batch Record Review and Batch Release, Shop floor management.
• To ensure GMP practices at manufacturing shop floor.
• To verify raw material dispensing activity.
• To approve batch coding details during packaging operation.
• Review of executed batch records and release for next processing stage.
• Preparation and review of CPV data trend.
• To perform impact assessment of breakdown memo.
• To initiate change control, unplanned and planned deviation wherever required.
• To review area, equipment, and cleaning log and tensure proper labelling.
• To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records.
• To perform calibration of IPQA instruments.
• To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials.
• To review and approve packaging artworks, proofs, and shade cards.
• To archive executed documents like BMR, BPR, Hold time Protocol etc..
• To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging.
  

Additional Responsibilities:

• To monitor and record the environmental condition of label control room.
• To prepare and revise functional SOPs, wherever required.
• Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.
  

Skills

• In-Process Checks & Monitoring - Advanced
• Batch Record Review - Advanced
• Compliance and Regulatory Knowledge - Advanced
• Internal Audits and Inspections - Advanced
• Document and Record Review - Advanced
• Line Clearance & Batch Record Review - Advanced
• Process Deviation Identification & Handling - Advanced
• Audit & Regulatory Inspection Readiness (USFDA, EMA, MHRA, EUGMP,WHO) - Intermediate
• Risk Assessment & Change Control - Mastery
  

Qualifications