Bioanalytical QA Executive

Conduct QA 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.

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

Review BA/BE study documents including study protocols, method validation documentation, 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 Pharma.

Review SOPs, GSOPs, Analytical Target Profiles (ATPs) and instrument qualification documentation including IQ/OQ/PQ/DQ.

Create, review, coordinate and implement QA Standard Operating Procedures (SOPs) and global documents such as GQSs/GSOPs, and support operational-level SOP development with R&D stakeholders.

Review Quality Management System (QMS) records including deviations, incidents, temporary change controls, investigations, CAPA and change controls.

Prepare audit reports within required timelines, identify non-compliance/non-conformance and immediately escalate critical issues to QA management where applicable.

Support regulatory inspections in collaboration with R&D stakeholders, including creation and implementation of appropriate CAPA and timely resolution of regulatory queries.

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

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

Experience or understanding of GCP/GLP quality programs and QA auditing practices.

Knowledge of auditing skills and quality compliance requirements in a BA/BE environment.

Knowledge and understanding of pharmacokinetics, statistical analysis and related tools is relevant to the role.

Knowledge of PBPK/PBBM studies is preferred.

Knowledge of IT/computer systems.

Ability to assess study documentation, raw data, reports, validation records, qualification records and QMS documentation for regulatory and procedural compliance.

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.

Job grade: G12A.

Travel requirement: Nil.

Help maintain the integrity, compliance and inspection readiness of Sun Pharma R&D BA/BE and bioanalytical activities.

Identify quality risks and non-conformances through structured auditing and document review.

Support effective CAPA implementation and resolution of regulatory gaps within defined timelines.

Strengthen quality systems, SOP governance, documentation practices and operational compliance across R&D.

Collaborate with R&D stakeholders and external service providers to ensure consistent application of applicable quality and regulatory expectations.

Drive to achieve results.

Ability to work effectively in a team.

Customer-centric approach.

Strong written and verbal communication skills.

Ability to collaborate with QA management, R&D stakeholders, CROs/CSPs and other relevant functions.