Bioanalytical QA Executive

Sun Pharmaceutical Industries, Inc.; Gurugram District; On-site; INR 700,000 - 900,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. is seeking an Executive - R&D Quality GCP QA in Gurugram to lead QA audits, review BA/BE studies, and implement SOPs across global documents. You will ensure GDP compliance and support regulatory inspections while fostering a collaborative QA culture.

The ideal candidate has 2–3 years in BA/BE QA, strong GCP/GLP knowledge, and good communication skills to drive quality across the R&D functions.

Qualifications

• 02–03 years in BA/BE QA environment with audit experience.
• Strong knowledge of GCP/GLP regulatory frameworks.
• Experience in auditing and QA SOP development.
• Familiarity with GDP and regulatory inspections.
• Understanding of pharmacokinetics and statistics concepts.

Responsibilities

• Audit BA/BE studies, including bioanalytical audits, PK and stats audits.
• Perform System/Facility/Process QA audits.
• Create/review & implement QA SOPs and global documents (GQS/GSOPs).
• Review study documents for BA/BE studies to ensure GDP compliance.
• Review PBPK/PBBM model reports generated in Sun Pharma.
• Review QMS records: deviations, incidents, change controls, CAPA.
• Prepare audit reports and elevate critical issues to QA management.
• Support regulatory inspections and CAPA for identified gaps.
• Assist in training on guidelines, regulations, and SOPs.

Skills

Audit skills

GCP/GLP knowledge

QA processes

SOP/GSOP creation

Pharmacokinetics knowledge

Statistical analysis tools

IT/computer systems

Teamwork

Communication skills

Education

Bachelor's degree in life sciences

Tools

PBPK modelling

QMS management systems

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Executive - R&D Quality GCP QA

Business Unit:

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.
• 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 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.

Nil

Job Requirements

Educational Qualification

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.

• 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.
• 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).