17 Aug
|
Sun Pharmaceutical
|
India
17 Aug
Sun Pharmaceutical
India
Job Title:
QC Head
Business Unit:
Sun Global Operations
Job Grade
Senior Manager
Location :
Sikkim II
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 secure 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.
📌 QC Head (India)
🏢 Sun Pharmaceutical
📍 India