Job Description:

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