Manager - R&D Quality CMC QA

Sun Pharma; Vadodara; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Sun Pharma is seeking a Manager – R&D Quality CMC QA in Baroda to lead pre-approval inspections for formulations and API across Sun and CMO sites. The role demands deep QA audit experience and strong regulatory knowledge to ensure on-time approval milestones.

The candidate will review documentation, manage audits, and coordinate with cross-functional teams to mitigate risks and drive compliance with USFDA/EU GMP standards. This is a leadership-focused, on-site role in Baroda.

Qualifications

• 10-12 years of auditing experience in pharmaceutical quality/production.
• Knowledge of USFDA and EU GMP regulations.
• Strong written and verbal communication, coordinating with multiple functions.
• Willingness to travel across different sites for extended periods.

Responsibilities

• Plan and execute pre-approval inspections for products/ APIs at Sun and Sun CMO sites with dossiers/DMF submissions.
• Understand manufacturing, packing processes and analytical methods; implement audit plans.
• Identify risk factors and ensure quality systems are audited to mitigate and close gaps before regulatory inspections.
• Communicate identified risks to stakeholders for mitigation and closure prior to regulatory reviews.
• Review documents and data from technology transfer and submission batches to ensure compliance with internal and regulatory standards.
• Review batch manufacturing/packing records, analytical records, qualification records, and related raw data/COA.
• Audit GMP documents such as Equipment/Process Qualification, Validation, Change Control, Deviations, Distribution, Batch release records.
• Handle calibration, preventive maintenance, temperature mapping, storage location records.
• Review stability data/reports and reconcile samples; ensure data integrity for release of products.
• Coordinate with auditors/auditees to compile observations, draft audit reports and secure closure.

Skills

Auditing

Quality systems

USFDA & EU GMP

Interdepartmental coordination

Travel readiness

Audit report writing

Education

M. Pharmacy / MSc

Job description

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 collaborative 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
• To understand manufacturing, packing process and analytical techniques development and execute audit plan.
• Identify risk factors and ensure quality system is audited to identify risk are mitigated and closed prior to pre-approval inspection by agency.
• Assure identified risk are communicated to respective stakeholder 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 inline to internal and regulatory requirements
• Batch manufacturing/packing records, analytical records, qualification records, associated raw data, electronic records etc.
• GMP documents associated submitted batches like Equipment Qualification, Process Qualification/Validation, Change Control, Deviations, Distribution, Batch release related records
• Calibration, preventive, 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 auditee to compile audit observations, prepare detailed audit report and verifying compliance for adequate closure.

Required Skills for the role

• Candidate shall have
  • 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
  • Shall be well versed with USFDA and EU GMP regulations
  • Shall be having good interpersonal communication and coordination amongst various functions
  • Shall be quick in understanding various formulation, analytical techniques, API process, etc
  • Shall be ready to travel across different sites for multiple days
  • Shall be well versed in writing audit reports, planning and coordinating discussion with cross functional team

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 employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).