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