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:
- Evaluate current systems and processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and Global Quality Systems/ SOPs (GQSs/ GSOPs) in collaboration with relevant stakeholders in R&D.
- Conduct the outsourced BA/BE study audits (both healthy volunteer and patient based) which include investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), In-process audits etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines.
- Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) Qualification/ Re-qualification audits.
- Verify adequacy of all created & executed CAPAs, including CAPA identified as a result of audit by corporate audit department, followed by adequacy and effectiveness check of implemented CAPAs.
- Harmonize the QA systems and processes, wherever applicable and feasible, across the organization for in-house and outsourced BA/BE Studies.
- Provide GCP QA oversight in creation/ review of study documents (e.g. study protocol, study plans, IB, ICFs, clinical study report etc.) for in-house and outsourced BA/BE studies in compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
- Support for conduct of regulatory inspection in collaboration with other R&D stakeholders involved in in-house and outsourced clinical studies. Collaborate for creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner.
- To be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and other regulations / guidelines related to in-house and outsourced clinical studies and advice on their use and compliance.
- Support to Regulatory query response and its review.
- Mentor and coach both the direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
