Purpose

Handling Deviation management, CAPA, Risk Assessments, Audit Compliance, and other QMS documentation

Position / Job Title

Officer

Department

QA-QMS

Reporting To

Section Head – QMS

Location

Satara

Years Of Experience

5+ years in handling of QMS activities

Dosage Form

Liquid (core area); multi-dosage experience including tablet, and sterile formulations will be an added advantage.

Job Responsibilities / Deliverables

Handle end-to-end deviation management, including initiation, investigation, root cause analysis, impact assessment, and timely closure in compliance with cGMP

requirements.

Initiate, track, and ensure effective implementation and closure of CAPA arising from deviations, audits, and other quality events.

Perform and facilitate risk assessments (e.g. FMECA, QRM) to evaluate impact on product quality, patient safety, and compliance.

Support and ensure compliance during internal and external audits, including

preparation, coordination, response to observations, and timely closure of audit findings.

Monitor and ensure compliance of QMS processes with regulatory requirements (US FDA, EU-GMP, MHRA, TGA).

Prepare trend analysis reports for deviations, CAPA effectiveness, and risk assessments to support continuous improvement.

Participate in self-inspections and follow-up for closure of identified gaps.

Coordinate with Production, QC, Engineering, and other departments for investigation, CAPA implementation, and audit readiness.

Qualifications & Pre-Requisites

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

Sound knowledge of QMS activities

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

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