Officer, IPQA
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed2–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
1 cGMP and compliance review in the GMP area as per cGMP guideline.
2 Machine and area clearance.
3 Sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample and In-process checks during execution of batch manufacturing Packaging as per Process Study Protocol (PSP), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) miscellaneous protocol based study.
4 Issuance of Bottle label, Outsert and Medication guide for commercial batch.
5 Documents and records review like equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record etc.
6 Calibration of IPQA instruments.
7 Supervision of dispensing activity of raw material and packaging material.
8 Review of executed Batch Manufacturing Record (BMR) Batch Packaging Record (BPR) and release for next stage.
Additional Responsibilities:
Additional Responsibilities:
- Ensure strict compliance with EHS policies, SOPs, and all applicable statutory and company safety requirements.
- Identify, report, and support the closure of unsafe conditions, unsafe acts, near misses, and incidents in a timely manner.
- Consistently use the prescribed Personal Protective Equipment (PPE) and maintain safe housekeeping practices within the work area.
- Actively participate in safety trainings, emergency drills, risk assessments (HIRA/JSA), and promote a strong safety culture.
Education:
- B. Pharm - Required
- M. Pharm - Preferred
Experience:
- 2 years or more in 2 - 5 Years
Specialized Knowledge: Licenses:
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
bprprocess validationCGMPcompliance reviewHIRASamplingehsRaw MaterialIPQABatch ManufacturingDispensingManufacturingcomplianceHousekeepingPackaging MaterialBatch Manufacturing Record
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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