Manager - R&D Quality CMC QA
Sun Pharmaceutical Industries Ltd · Baroda, Rajasthan, India
Pharmaceutical Manufacturing · 10,001+ employees
About the role
The manager is responsible for planning and executing pre-approval inspections at various manufacturing sites to ensure regulatory compliance for product dossiers and DMFs. They must identify and mitigate quality risks while coordinating with cross-functional teams to verify audit closure.
What they look for
Requirements
Candidates must possess 10-12 years of experience in pharmaceutical quality or production with a strong background in USFDA and EU GMP regulations. A postgraduate degree in Pharmacy or Science is required, along with the ability to travel frequently to different sites.
Benefits
Full 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).
