Bioanalytical QA Executive

SUN PHARMA; Gurugram District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharma in Gurugram is seeking an Executive – R&D Quality GCP QA to lead QA audits of BA/BE studies, CRO/CSP qualifications, and SOP governance. You will review study documents for GDP compliance and support regulatory readiness.

The role requires 2–3 years in BA/BE QA with knowledge of GCP/GLP and pharmacokinetics, backed by IT systems familiarity. Expect a challenging, growth-oriented environment at Sun Pharma.

Qualifications

• Graduate or post-graduate degree in basic sciences.
• 2-3 years of BA/BE QA experience.
• PBPK/PBBM knowledge preferred.
• Understanding of GCP/GLP regulations.

Responsibilities

• Audit BA/BE studies including bioanalytical audits and pharmacokinetic audits.
• Conduct System/Facility/Process QA audits.
• Create and review QA SOPs and global documents with R&D stakeholders.
• Perform CRO/CSP/Material supplier qualification audits.
• Review study documents to ensure GDP compliance.
• Review PBPK/PBBM model reports generated at Sun Pharma.
• Review SOPs, ATP, IQ/OQ/PQ/DQ, and QMS records.
• Prepare audit reports and raise non-conformances to QA management.
• Support regulatory inspections and CAPA for gaps.

Skills

GCP/GLP knowledge

Auditing skills

Pharmacokinetics

Statistics

IT systems

Education

Minimum graduate / post graduate degree in basic sciences

Tools

PBPK/PBBM modeling

Job description

Job Title

Executive – R&D Quality GCP QA

Business Unit

Sun R&D Quality

Job Grade

G12A

Location

Gurugram
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment 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 collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities

• Conduct audit of BA/BE studies, which includes bioanalytical in-process audits, bioanalytical retrospective audits, pharmacokinetic and statistical audits etc.
• Perform other QA audits like System/Facility/Process based audits.
• Create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs). Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D.
• Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
• Review study documents (e.g. study protocol, method validation and study raw data/ reports etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
• Review Physiologically Based Pharmacokinetic (PBPK) / Physiologically Based Biopharmaceutics (PBBM) model report(s) generated at Sun Pharmaceutical Industries Limited.
• Review SOPs/ GSOPs, ATP, instrument qualification (IQ/OQ/PQ/DQ) etc.
• Review QMS records including Deviation, Incident, Temporary change control, Investigation, CAPA and change control etc.
• Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and elevate any critical issue immediately with the QA management, as applicable.
• Support for conduct of regulatory inspection in collaboration with other R&D stakeholders. Collaborate for creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time bound manner
• Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.

Travel Estimate

Nil

Job Requirements

Educational Qualification

Minimum graduate / post graduate degree in basic sciences

Experience

Tenure : At least 02-03 years of experience in BA/BE environment, preferably in QA. Experience in conducting/ reviewing Physiologically Based Pharmacokinetic (PBPK) / Physiologically Based Biopharmaceutics (PBBM) studies preferred.

Technical Competencies

• Understanding of international GCP/ GLP regulations and clinical research processes.
• Experience/ Understanding of GCP/ GLP Quality programs.
• Knowledge and understanding of auditing skills.
• Knowledge and understanding of pharmacokinetics and statistical analysis and tools preferred.
• Knowledge of IT/computer systems.

Behavioral Competencies / Soft Skills

• Drive to achieve results
• Ability to work in team
• Flair for customer centricity
• Good written and verbal communication skills

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).