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.”
Job Profile:
- 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.
- Perform Project-based, Process-based and Facility-based reviews of BA/BE study operations (including Bioanalytical, Pharmacokinetic and statistical).
- Perform In-process reviews of Lab activities.
- Review of method validation Raw data and BA/BE study raw data for accuracy, integrity, compliance and completeness.
- Review of method validation reports and BA/BE study reports to ensure that they accurately reflect the raw data and BA/BE study conduct.
- Review of Pharmacokinetic and Statistical data for compliance to SOPs, study protocol and regulatory requirements.
- Provide appropriate CAPA (Corrective Action and Preventive Action) to Quality Assurance audit reports.
- Prepare, review and revise departmental SOPs in accordance with regulatory requirements, GSOP and GQS.
- Document control of all raw data forms, paper laboratory notebooks and logbooks in the department.
- 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.
- Review contract service provider assessment records and qualification documents.
- Support in providing scientifically rational responses to queries raised by regulatory agencies on submitted bioavailability/ bioequivalence reports.
- Support in providing cogent and logical responses/clarifications to observations given by Regulatory Agencies during inspection/audit of bioequivalence study/site.
- 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.
- 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.
