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Title: Manager - R&D; Quality CMC QA
Date: Aug 6, 2026
Location: Tandalja - R&D;
Company: Sun Pharmaceutical Industries Ltd
Job Title: Manager - R&D; Quality CMC QA
Business Unit: Global Quality & Compliance
Job Grade: G11A
Location: Baroda

At Sun Pharma, we commit to helping you "Create your own sunshine"- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we 'Thrive together' and support each other's journeys.

Position Summary

This position shall be responsible for identifying, planning, conducting product pre-approval inspection (PAI) at various Sun and Sun CMO sites (Formulation & API) from where product dossiers/DMF's are submitted to the regulatory agencies in order to assure on-time drug product/API approval.

Key Responsibilities:

- Plan and execute pre-approval inspection for various products/API executed at Sun and Sun CMO sites from where dossiers/DMF's are submitted.
- Understand manufacturing, packing process and analytical techniques development and execute audit plan.
- Identify risk factors and ensure quality system is audited to identify risks and ensure they are mitigated and closed prior to pre-approval inspection by agency.
- Assure identified risks are communicated to respective stakeholders for appropriate risk mitigation and closed prior to pre-approval inspection by regulatory agency.
- Review various documents, records, and data generated during execution of technology transfer and submission batches in line with internal and regulatory requirements:
- Batch manufacturing/packing records, analytical records, qualification records, associated raw data, electronic records, etc.




- GMP documents associated with submitted batches like Equipment Qualification, Process Qualification/Validation, Change Control, Deviations, Distribution, Batch release related records.
- Calibration, preventive maintenance, temperature mapping, storage location records.
- Stability data/reports, verify sample reconciliation, raw material, in process, finished product release raw data, and COA.
- Development reports which are part of submission documents like Method Validation, Method Transfer, Impurity Characterisation, Product Development Report, etc.

- Co-ordination and follow up with auditors and auditees to compile audit observations, prepare detailed audit report and verify compliance for adequate closure.

Required Skills for the Role

- Good technical understanding of formulation product manufacturing and analytical process for Non oral and Oral formulations including drug-device combinations and API Process.
- 8-10 years of auditing experience for quality systems.
- Well versed with USFDA and EU GMP regulations.
- Robust interpersonal communication and coordination amongst various functions.
- Quick understanding of various formulation, analytical techniques, API processes, etc.
- Willingness to travel across different sites for multiple days.
- Proficient in writing audit reports, planning and coordinating discussions with cross-functional teams.

Travel Estimate

Job Requirements

Educational Qualification

- M. Pharmacy / MSc

Experience

- Tenure: 10-12 years of experience in Pharmaceutical Quality/Production function.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and

📌 Title: Manager - R&D Quality CMC QA (India)
🏢 SUN PHARMA
📍 India