QC Head

Role overview

This position is for a Quality Control Head within Sun Global Operations, based at Sikkim II in Sikkim, India. The role is placed at Senior Manager level and is focused on leading QC operations in a regulated pharmaceutical environment.

About the company

The organisation emphasizes a culture of continuous improvement, ownership, and teamwork. Employees are encouraged to keep progressing each day, take responsibility for their work, and collaborate effectively with colleagues.

Key responsibilities

• Maintain full compliance with cGMP, GLP, and applicable regulatory frameworks, including WHO, Revised Schedule M, and ICH requirements.
• Keep the laboratory inspection-ready and take the lead in handling audit responses.
• Review and sign off on specifications, SOPs, protocols, and analytical documentation.
• Ensure data integrity practices are followed, including ALCOA+, along with compliance to 21 CFR Part 11.
• Supervise chemical analysis and instrumental testing work involving HPLC, GC, UV, and dissolution systems.
• Make sure sampling, testing, and reporting are completed within the required timelines.
• Oversee laboratory facilities, equipment calibration, and preventive maintenance activities.
• Promote safe working practices and ensure the lab operates in a compliant manner.
• Examine and approve results for raw materials, packaging materials, finished products, and Certificates of Analysis.
• Verify that work aligns with pharmacopoeial standards as well as internal quality standards.
• Prepare and approve stability protocols in line with ICH guidelines, monitor stability chambers and trend data, and ensure stability samples are assessed and reported on time.
• Direct investigations related to OOS, OOT, and deviation cases.
• Ensure CAPA actions are implemented effectively and closed in a timely manner.
• Carry out root cause analysis and track quality trends for recurring issues.
• Guide analytical method development, validation, and transfer while ensuring methods remain robust, repeatable, and compliant.
• Review audit trails and electronic records for accuracy and compliance.
• Work closely with ADL, R&D, QA, Production, Engineering, and Regulatory Affairs teams.
• Support product development, scale-up, and technology transfer initiatives.
• Assess analytical data generated by third-party laboratories.
• Lead, coach, and develop the QC team while building a strong quality-focused culture.
• Conduct performance reviews and support skill-building programs for team members.
• Manage the QC budget, including instruments, reagents, and consumables, while improving resource use and cost efficiency.
• Drive improvements in laboratory productivity and automation.
• Track QC performance metrics and implement corrective improvements.

Requirements

• M.Sc. in Chemistry is required.
• The role calls for more than 5 years of experience in a QC Head position.
• Overall experience of 18 to 20 years is expected.

Additional information

Travel may be required for this role, though no specific estimate has been provided.

This job description is intended to describe the general nature and level of the work. Responsibilities and requirements may be adjusted over time, and comparable duties may be assigned based on business needs and the incumbent’s experience.

Employer value proposition

The company highlights employee growth, support, and long-term impact, with an environment designed to encourage both professional and personal development.