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 team-oriented 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.

📌 QC Head (Gangtok)
🏢 Sun Pharmaceutical Industries
📍 Gangtok