Sun Pharma looking for Senior Manager

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Sr.Manager - R&D Quality GCP QA

Job Description
• 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.

Candidate Profile
Minimum graduate / post graduate degree in basic sciences
At least 14 years of experience in GCP environment of which at least 06 years’ experience must be in Quality Assurance (QA).

Technical Competencies
• High level of understanding of local and international GCP regulations and clinical research processes including of outsourced studies.
• Experience of implementing GCP Quality programs and conducting GCP audits
• Experience of qualification of CROs/CSPs/ Material suppliers.
• Experience of conducting internal and external audits.
• Experience in handling regulatory agency inspections at sites
• Excellent auditing skills.
• Ability to lead, manage and motivate people with a variety of skill sets
• Good knowledge of IT/computer systems.

Behavioral Competencies / Soft Skills
• Drive results and excellence.
• Excellent customer centricity and problem-solving skills.
• Good communication skills with the ability to communicate effectively with all levels within organization.
• Ability to work independently

Additional Information
Experience : 14 years of experience
Qualification : graduate / post graduate degree
Location : Vadodara
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D Quality GCP QA
End Date : 30th September 2026