Officer

Purpose

To perform IPQA activities, ensure compliance with cGMP requirements, and conduct batch record review for timely product release.

Position / Job Title

QA Officer

Department

QA - IPQA

Reporting To

Section head

Location

Satara

Years Of Experience

2-3 years experience in Quality Assurance

Dosage Form

Liquid (core area); experience in other dosage forms will be an added advantage.

Job Responsibilities / Deliverables

Shop floor activities:

Conduct in-process checks (IPQC) and proof checking during manufacturing and packing operations.

Carry out pack line inspection and sampling of bulk finished and finished products.

Perform sampling and execution support for process validation and cleaning validation activities.

Ensure status labeling of materials, equipment, and areas is maintained as per SOP.

Monitor shop floor activities through routine QA rounds and identify/report any discrepancies or non-compliance.

Verify dispensing activities to ensure compliance with BMR/BPR.

Review environmental conditions (temperature, humidity, differential pressure) during operations.

Ensure GDP (Good Documentation Practices) compliance on the shop floor.

Issue, review, and reconcile Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).

Perform real-time documentation review to avoid errors and ensure right-first-time execution.

Review audit trails of production equipment/instruments (where applicable).

Ensure completeness and compliance of batch release documentation and support archival of records.

Identify, report, and initiate deviations observed during shop floor activities.

Support investigation and CAPA implementation related to shop floor events

Qualifications & Pre-Requisites

B. Pharm / M. Pharm With relevant experience in pharma quality assurance

Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.

Familiarity with Liquid Oral dosage forms and/or potent formulations, Sterile, Nasals, OSD (optional)

Effective communication, Team coordination and work in collaboration within compliance

Good understanding of GDP and Data Integrity requirements

Additional Notes

Role is expected to work in all shifts and all days of the week.

Will have to handle any other responsibility, if allocated.