Officer
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