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:
- Conduct audit of BA/BE studies, which includes bioanalytical in-process audits, bioanalytical retrospective audits, pharmacokinetic and statistical audits etc.
- Perform other QA audits like System/Facility/Process based audits.
- 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 Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
- Review study documents (e.g. study protocol, method validation and study raw data/ reports etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
- Review Physiologically Based Pharmacokinetic (PBPK) / Physiologically Based Biopharmaceutics (PBBM) model report(s) generated at Sun Pharmaceutical Industries Limited.
- Review SOPs/ GSOPs, ATP, instrument qualification (IQ/OQ/PQ/DQ) etc.
- Review QMS records including Deviation, Incident, Temporary change control, Investigation, CAPA and change control etc.
- Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the QA management, as applicable.
- Support for conduct of regulatory inspection in collaboration with other R&D stakeholders. Collaborate for creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner
- Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.
