Description:
This role ensures GMP and GxP compliance in dispensing, manufacturing, and packaging. Responsibilities include machine and area clearance, product sampling, in-process checks, batch record reviews, and raw material verification. The position also involves approving packaging details, reviewing environmental and calibration records, managing change controls and deviations, and ensuring proper labelling and document archiving.
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
Monitors production processes in real-time to ensure compliance with specifications and GMP - Intermediate
Qualifications
Education: B. Pharm M.Sc / M.Pharm
Experience: 7 years or more in 7- 9 years
Expert in IPQA related all the key functions.
