Purpose

To perform IPQA activities, ensure compliance with cGMP requirements, oversee shop floor QA operations, and review batch records for timely product release.

Position / Job Title

QA Officer

Department

QA - IPQA

Reporting To

Section head

Location

Satara

Years Of Experience

Years of Experience 5–7 years of experience in pharmaceutical Quality Assurance, with exposure to IPQA and team handling

Dosage Form

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

Job Responsibilities / Deliverables

Plan and allocate IPQA manpower across shifts and production areas to ensure adequate coverage

Supervise and monitor IPQA officers for effective execution of shop floor activities

Review and verify IPQA observations, logbooks, and checklists for completeness and accuracy

Ensure uniform implementation of SOPs and GMP practices across all shifts

Provide guidance, on-the-job training, and mentoring to IPQA team members

Perform second-level review of critical documents and escalation of quality issues

Ensure timely closure of deviations, CAPAs, and compliance actions related to IPQA

Act as a point of contact during audits for IPQA-related activities

Drive continuous improvement initiatives and strengthen shop floor compliance culture

Shop Floor IPQA Activities (Individual Role)

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

Monitor shop floor through QA rounds and identify/report discrepancies or non- compliance

Verify dispensing activities for compliance with BMR/BPR Ensure GDP compliance on the shop floor

Issue, review, and reconcile BMR/BPR

Review of master batch records

Ensure completeness of batch release documentation and support archival

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

Support investigation and CAPA implementation

Qualifications & Pre-Requisites

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

Strong knowledge of IPQA activities, cGMP, and shop floor compliance

Experience in handling teams or acting as shift in-charge preferred

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)

Strong communication, leadership, and coordination skills

Good understanding of GDP and Data Integrity requirements

Additional notes

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

Flexibility to take on additional responsibilities as assigned by management

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.