Officer, IPQA

Amneal Pharmaceuticals; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a QA/IPQA professional to ensure cGMP compliance and proper GMP execution across manufacturing and packaging processes.

The role requires 2+ years in QA/IPQA, B.Pharm is mandatory and M.Pharm is preferred. Responsibilities include documentation review, sampling at multiple stages, and ensuring accurate records and instrument calibration.

Qualifications

• B.Pharm required; M.Pharm preferred.
• 2+ years experience in QA/IPQA (2–5 years).
• Specialized knowledge: licenses as applicable to QA/IPQA.

Responsibilities

• Review cGMP compliance in GMP areas as per guidelines.
• Perform machine and area clearances and sampling at various stages.
• Review BMR/BPR and release for next stage; ensure proper documentation.

Skills

cGMP knowledge

GMP compliance

IPQA calibration

Education

B. Pharm

M. Pharm

Tools

IPQA instruments

Job description

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.

Education:

• B. Pharm - Required
• M. Pharm - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses: