Sr.Executive-QC for Bioanalytical Lab - CPP

Job Title:

Sr. Executive

Business Unit:

CPP

Job Grade

G11B

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.”

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Job Profile:

1. Perform QC review of departmental operations to ensure compliance to SOPs, study protocol, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), quality standards and regulatory requirements.


2. Perform Project-based, Process-based and Facility-based reviews of BA/BE study operations (including Bioanalytical, Pharmacokinetic and statistical).


3. Perform In-process reviews of Lab activities.


4. Review of method validation Raw data and BA/BE study raw data for accuracy, integrity, compliance and completeness.


5. Review of method validation reports and BA/BE study reports to ensure that they accurately reflect the raw data and BA/BE study conduct.


6. Review of Pharmacokinetic and Statistical data for compliance to SOPs, study protocol and regulatory requirements.


7. Provide appropriate CAPA (Corrective Action and Preventive Action) to Quality Assurance audit reports.


8. Prepare, review and revise departmental SOPs in accordance with regulatory requirements, GSOP and GQS.


9. Document control of all raw data forms, paper laboratory notebooks and logbooks in the department.


10. Perform the role of Department Training Coordinator. Conduct and coordinate induction training for new joiners and ongoing training sessions in the department and maintain training records for department personnel.


11. Review contract service provider assessment records and qualification documents.


12. Support in providing scientifically rational responses to queries raised by regulatory agencies on submitted bioavailability/ bioequivalence reports.


13. Support in providing cogent and logical responses/clarifications to observations given by Regulatory Agencies during inspection/audit of bioequivalence study/site. 


14. Perform monitoring of outsourced studies conducted at Contract Research Organizations (CROs) and review data and reports from these CROs for compliance to study protocol and regulatory requirements.


15. Ensure adherence to EHS policies, procedures, rules and regulations.

Competencies Required:

• GCP, GLP, and GDP trained professional with hands-on experience in bioanalytical data generation or quality control review in compliance with regulatory standards.


• Should have Stability in career, Strong time management, Cross-functional coordination and good communication

              Data review expertise & Quality control unit of Bio analytical Setup/Lab experience.

Job Requirements

Educational Qualification –

M.Pharma in Quality Assurance

Experience –

Tenure:  4+ years

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).