Officer, IPQA
Summary
Oversee pharmaceutical manufacturing quality by reviewing compliance, sampling materials, and validating batch records in a cGMP-regulated environment.
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:
- 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: