Manager, IPQA
Amneal Pharmaceuticals
- Location
- Ahmedabad, Gujarat, India
- Job type
- Full-time
About the role
Amneal Pharmaceuticals
Website:
amneal.com
Job details:
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.
Additional Responsibilities
- 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.
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) B. Pharma - Preferred
- Master Degree (MS/MA) M. Pharma - Preferred
Experience
- 12 years or more in 12-14 years
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