Job Description
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
