QC Head

SUN PHARMA; Sikkim; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Sun Pharma is seeking a Sr. Manager (QC Head) in Sikkim to lead the QC function within Sun Global Operations. The role requires steering cGMP/compliance, audit readiness, and managing analytical methods, data integrity, and CAPA across QA, R&D, Production, and Regulatory Affairs.

The incumbent will develop and train the QC team, manage budgets, and drive efficiency, calibration, maintenance, and instrument performance to ensure high-quality outputs and regulatory compliance.

Qualifications

• M.Sc Chemistry
• Tenure : Minimum 18 years with 5 years of experience as QC Head

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, COAs
• Ensure compliance with pharmacopoeial and in-house standards.
• Design and approve stability protocols as per ICH guidelines.
• Lead investigations for OOS, OOT, Deviations.
• Ensure effective CAPA implementation and closure.
• Perform root cause analysis and trend monitoring.
• Oversee analytical method development, validation, and transfer.
• 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.
• 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

Education

M.Sc Chemistry

Job description

Sr. Manager (QC Head)

Business Unit

Sun Global Operations

Job Grade

G9A

Location

Sikkim I

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

Job Requirements

M.Sc Chemistry

Experience

Tenure : Minimum 18 years with 5 years of experience as QC Head

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).