Bioanalytical QA Executive

SUN PHARMA; Gurgaon; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharma is seeking an Executive – R&D Quality GCP QA in Gurugram. You will lead QA audits across BA/BE studies, ensure GDP/compliance, and drive SOP development in collaboration with R&D teams.

The role requires 2–3 years in BA/BE QA, strong auditing skills, and knowledge of GCP/GLP principles. You will engage with CROs/CSPs and support regulatory inspections, contributing to Sun Pharma's commitment to quality and compliance.

Qualifications

• Minimum graduate / post graduate degree in basic sciences.
• 2–3 years BA/BE/QA experience; PBPK/PBBM preferred.
• Understanding of GCP/GLP regulations and clinical research processes.
• Auditing knowledge and skills.
• Knowledge of IT/computer systems.

Responsibilities

• Conduct BA/BE audits including bioanalytical in-process and retrospective audits.
• Perform System/Facility/Process QA audits.
• Create and implement SOPs and global documents; review SOPs with R&D.
• Audit CRO/CSP/Material supplier qualifications.
• Review study documents for BA/BE studies to ensure GDP compliance.
• Review PBPK/PBBM model reports.
• Review SOPs, ATP, IQ/OQ/PQ/DQ.
• Review QMS records: deviations, incidents, CAPA and change control.
• Prepare audit reports and raise non-conformances; coordinate CAPA.
• Support regulatory inspections with R&D; address regulatory queries.
• Impart training on guidelines, regulations, SOPs.

Skills

GCP/GLP awareness

QA quality programs

Auditing skills

Pharmacokinetics knowledge

Statistical analysis

IT systems knowledge

Education

Graduate or Postgraduate in basic sciences

Job description

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: 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).