Senior Executive - R&D Quality- GCP QA

Job Title

Senior Executive - R&D Quality- GCP QA

Business Unit

Global Quality & Compliance

Job Grade

G11B

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.”

Key Responsibilities

• Create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs). Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D.
• Conduct audit of BA/BE studies, which includes in-process audits, retrospective audits etc.
• Conduct sponsor QA oversight audits for outsourced BA/BE Studies (conducted in healthy volunteers).
• Perform other QA audits like System/Facility/Process based audits.
• Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
• Review study documents (e.g. study protocol, study plans, IB, ICFs, clinical study raw data/ report etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
• Review Deviation, Incident, Investigation, CAPA and change control, instrument qualification (IQ/OQ/PQ/DQ) etc.
• Review and approve documents related to Computer System Validation.
• Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the senior management (Head, GCP QA/ Head- Site GCP QA and Quality R&D Head), as applicable.
• Support creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards. Verify adequacy of all created & executed CAPAs.
• Responsible for document control and document management.
• Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.
  
  

Travel Estimate

Low

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure : 6 to 10 Yrs

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).