Job Description

Job Title

Sr.Manager – R&D; Quality GCP QA

Business Unit

Global Quality & Compliance

Job Grade

Senior Manager

Location :

Vadodara

At Sun Pharma, we commit to helping you Create your own sunshine— by fostering an workplace 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 cooperative 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 w

📌 Sr Manager R&d Quality Gcp Qa Vadodara
🏢 SUN PHARMA
📍 Vadodara