Bioanalytical QA Executive

About the Role

Join Sun Pharma as an Executive in R&D Quality GCP QA based in Gurugram, contributing to a culture that encourages personal growth, ownership, and collaborative success. The company fosters continuous improvement, self-leadership, and teamwork in a supportive environment.

Key Responsibilities

• Conduct comprehensive audits of bioanalytical and bioequivalence studies, including in-process, retrospective, pharmacokinetic, and statistical audits.
• Perform audits related to systems, facilities, and processes to ensure quality compliance.
• Develop, review, and implement Quality Assurance Standard Operating Procedures (SOPs) and global documentation; support operational SOP creation in coordination with R&D stakeholders.
• Execute qualification and re-qualification audits for Contract Research Organizations (CROs), Contract Service Providers (CSPs), and material suppliers.
• Review study-related documents, such as protocols, method validations, raw data, and reports, ensuring alignment with regulatory guidelines and Good Documentation Practices.
• Assess reports generated from Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics (PBBM) models conducted within the organization.
• Evaluate SOPs, global SOPs, Analytical Test Procedures, instrument qualification documents (IQ, OQ, PQ, DQ), and Quality Management System records including deviations, incidents, change controls, investigations, and CAPA activities.
• Prepare audit reports promptly, flag critical non-compliances or non-conformances to QA management immediately.
• Support regulatory inspections by working closely with R&D teams and assist in creating and implementing corrective and preventive action plans to address identified gaps and queries within deadlines.
• Provide or assist in training sessions covering applicable regulations, guidelines, and SOPs.

Additional Information

Estimated travel for this role is negligible.

Qualifications and Experience

• Possess a minimum bachelor's or postgraduate degree in basic sciences.
• Hold at least 2–3 years’ experience in bioanalytical or bioequivalence environments, preferably within quality assurance.
• Experience or familiarity with auditing or reviewing PBPK/PBBM studies is advantageous.

Technical Skills

• Strong understanding of international Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations and clinical research workflows.
• Knowledge of quality programs under GCP and GLP.
• Competence in auditing practices and pharmacokinetics, alongside statistical analysis tools.
• Familiarity with information technology and computer systems used in the domain.

Behavioral Competencies

• Result-oriented attitude with drive to achieve goals.
• Ability to collaborate effectively within teams.
• Customer-focused mindset.
• Strong written and verbal communication skills.

About Sun Pharma

Sun Pharma prioritizes employee success and wellness through comprehensive benefits and growth opportunities, inviting you to join a place where continuous learning and impactful collaboration thrive.

Disclaimer

The job description summarizes the general nature and level of work expected, but additional duties consistent with the role and candidate expertise may be assigned or modified by the employer as needed.