PurposePreparation of Annual Product Quality Review (APQR)Position / Job TitleSr. OfficerDepartmentQuality AssuranceReporting ToAGM, In-Process Quality AssuranceLocationAmbernath Years of Experience5 to 6 YearsDosage FormSolid Oral/ Nasal Job Responsibilities / Deliverables
• Preparation of Annual Product Quality Review (APQR)
• Compilation of Data from Batch Documents, SAP, eQMS and from other appropriate sources to compile the raw data for APQR preparation.
• Review of Batch Manufacturing and Packing Records
• Support in investigation of customer complaints
• Preparation of Continuous Process Verification and CpK assessments
• Performing investigation for Out of Trend results of in-process parameters and quality parameters that identified during the trend data assessment
• In-process quality assurance and shopfloor rounds




• Submission of documents required for APR to RA
• Issuance of documents through electronic Document Management System
• Timely and proactively escalating issues. Qualifications & Pre-Requisites Must-Have

Skills:
• B. Pharm/ M. Pharm 5 to 6 years of experience in pharma quality assurance.
• Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional).
• Effective communication, and work in collaboration with cross functional team within compliance Additional Notes
• Role is expected to work in all shifts and all days of the week.
• Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.

📌 Senior Officer (Ulhasnagar)
🏢 Rubicon Research
📍 Ulhasnagar