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:
- Ensure adherence to cGMP, GLP, and regulatory requirements (WHO, Revised Schedule M, ICH)
- Maintain inspection readiness and lead responses during audits.
- Approve specifications, SOPs, protocols, and analytical reports.
- Ensure compliance with data integrity (ALCOA+) and 21 CFR Part 11
- Oversee Chemical, Instrumentation (HPLC/GC/UV/Dissolution).
- Ensure timely sampling, testing, and reporting.
- Manage laboratory infrastructure, calibration, and preventive maintenance.
- Ensure safe and compliant laboratory practices.
- Review and approve Raw material, packaging material, and finished product results, Certificates of Analysis (COAs)
- Ensure compliance with pharmacopoeial and in-house standards.
- Design and approve stability protocols as per ICH guidelines. Monitor stability chambers and data trends. Ensure timely evaluation and reporting of stability samples.
- Lead investigations for OOS (Out-of-Specification), OOT (Out-of-Trend), Deviations.
- Ensure effective CAPA implementation and closure.
- Perform root cause analysis and trend monitoring.
- Oversee analytical method development, validation, and transfer. Ensure methods are robust, reproducible, and regulatory compliant.
- Review audit trails and electronic data.
- Collaborate with ADL, R&D, QA, Production, Engineering, and Regulatory Affairs.
- Support product development, scale-up, and technology transfer
- Review third-party analytical data
- Lead, train, and develop QC team. Promote a strong quality culture.
- Conduct performance evaluations and skill development programs
- Manage QC budget (instruments, reagents, consumables). Optimize resource utilization and cost efficiency
- Drive laboratory efficiency and automation initiatives
- Monitor QC performance metrics and implement improvements
