QC Head

Sun Pharmaceutical Industries, Inc.; Sikkim; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a QC Head with over 18 years of experience in quality control management. The role involves ensuring adherence to cGMP, GLP, and regulatory requirements while overseeing laboratory operations and team development.

The ideal candidate should possess strong analytical skills, be able to lead audits and investigations, and drive the QC team's performance. At Sun Pharma, we prioritize your success and offer robust benefits to foster growth.

Qualifications

• Over 5 years of experience as QC Head.
• Overall 18 to 20 years in quality control and laboratory management.
• Strong knowledge of cGMP, GLP, and regulatory requirements.

Responsibilities

• Ensure adherence to cGMP, GLP, and regulatory requirements.
• Lead responses during audits and maintain inspection readiness.
• Oversee analytical method development and validation.
• Manage QC budget and optimize resource utilization.

Skills

Quality Control Management

Root Cause Analysis

Regulatory Compliance

Analytical Method Validation

Job description

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

Tenure: >5 years of experience as QC Head - Overall 18 to 20 Years

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!

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).