:

Purpose

Handling Customer Complaint investigations, Change controls, PQRs and other QMS documentation

Position / Job Title

Officer

Department

Quality Assurance

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 investigation of customer complaints, including root cause analysis, impact assessment, and timely closure in compliance with cGMP requirements.

Responding to customer communications and queries.

Evaluate, initiate, and manage change controls, ensuring proper impact assessment on product quality, regulatory compliance, and validated state of systems.

Prepare and review PQR reports by compiling and trending data such as deviations, complaints, OOS/OOT, and stability results.

Participate in self-inspections.





Preparation of presentations and MOM for Management Review Meetings, weekly report and follow-up for action closures.

Co-ordinate with Production, QC, Engineering, and other departments for investigation, change implementation, and QMS activities.

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

📌 Officer Satara
🏢 Rubicon Research
📍 Satara