Executive – R&D Quality GCP QA

Conduct quality audits of BA/BE studies, including bioanalytical in-process audits, bioanalytical retrospective audits, pharmacokinetic audits, and statistical audits.

Perform system-, facility-, and process-based QA audits.

Create, review, coordinate, and implement Quality Assurance SOPs and global documents such as GQSs and GSOPs.

Review and support creation of operational-level SOPs in collaboration with relevant R&D stakeholders.

Conduct qualification and re-qualification audits of Contract Research Organizations (CROs), Contract Service Providers (CSPs), and material suppliers.

Review BA/BE study documentation, including study protocols, bioanalytical method validation documents, study raw data, and reports, to verify compliance with applicable guidelines, regulations, and Good Documentation Practice (GDP).

Review Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics (PBBM) model reports generated at Sun Pharmaceutical Industries Limited.

Review SOPs, GSOPs, Analytical Test Procedures (ATP), and instrument qualification documentation, including IQ/OQ/PQ/DQ.

Review Quality Management System records such as deviations, incidents, temporary change controls, investigations, CAPA, and change controls.

Prepare audit reports within established timelines and identify non-compliance/non-conformance.

Immediately escalate critical quality issues to QA management when applicable.

Support regulatory inspections in collaboration with R&D stakeholders.

Collaborate on creation and implementation of appropriate CAPA for identified gaps and support timely resolution of regulatory queries.

Impart or assist with training on applicable guidelines, regulations, SOPs, and quality requirements.

Understanding of international GCP and GLP regulations and clinical research processes.

Experience or understanding of GCP/GLP quality programs.

Strong understanding of auditing principles and practices.

Understanding of BA/BE study environments and quality requirements.

Knowledge of Good Documentation Practice (GDP).

Ability to assess study protocols, method validation, raw data, reports, SOPs, analytical procedures, and instrument qualification records.

Knowledge of pharmacokinetics and statistical analysis/tools is preferred.

Knowledge of IT/computer systems.

Minimum graduate or postgraduate degree in Basic Sciences.

At least 2-3 years of experience in a BA/BE environment, preferably in QA.

Experience conducting or reviewing PBPK/PBBM studies is preferred.

Role is part of Sun R&D Quality and carries the job grade G12A.

Results-oriented approach and drive to achieve objectives.

Ability to work effectively as part of a team.

Customer-centric mindset.

Good written and verbal communication skills.

Strong attention to compliance, documentation, quality, and audit findings.

Location: Gurugram, Gurgaon office.

Work arrangement: Office-based/onsite.

Travel estimate: Nil.

Sun Pharma describes its workplace approach around continuous improvement, self-drive, taking ownership, collaboration, and professional growth.

The company states that employee success and well-being are priorities and highlights benefits and opportunities intended to support personal and professional development.

The role provides exposure to R&D Quality, GCP/GLP compliance, BA/BE studies, regulatory inspections, CRO/CSP qualification, CAPA, audit management, and PBPK/PBBM activities.