At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering
an setting 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