Senior Officer

Rubicon Research; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Rubicon Research in Mumbai seeks a QA professional with 5–6 years of pharma quality experience to lead APQR preparation, data compilation from SAP/eQMS, and review of batch records. The role supports investigations of customer complaints and CPk assessments, with emphasis on compliance and rapid issue escalation.

The candidate will participate in CPV activities, in-process QA, and shopfloor rounds, and will ensure timely document submissions for regulatory filings.

Qualifications

• Bachelor of Pharmacy or Master of Pharmacy with 5–6 years of QA experience.
• Experience with APQR preparation and batch data reconciliation.
• Exposure to OSD, Liquid Orals, Nasal forms.

Responsibilities

• Prepare Annual Product Quality Review (APQR).
• Compile data from batch documents, SAP, and eQMS for APQR.
• Review Batch Manufacturing and Packing Records.
• Support investigations of customer complaints.
• Prepare CPk assessments and Continuous Process Verification.
• Investigate Out of Trend results in process and quality data.
• In-process QA and shopfloor rounds.
• Submit documents for APR to Regulatory Authority.
• Issue documents through electronic Document Management System.
• Escalate issues timely and proactively.

Skills

Effective communication

Cross-functional collaboration

Quality assurance

Education

B. Pharm / M. Pharm

Tools

SAP

eQMS

Job description

Job Responsibilities / Deliverables

• Preparation of Annual Product Quality Review (APQR)
• Compilation of Data from Batch Documents, SAP, eQMS and from other appropriate sourcesto compile the raw data for APQR preparation.
• Review of Batch Manufacturing and Packing Records
• Support ininvestigation 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 ofdocuments 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.