Quality Control Manager

About the role

Granules Pharmaceuticals Inc. (GPI), a subsidiary of Granules India LTD, is a leading generic pharmaceutical company dedicated to excellence in manufacturing, quality, and commercialization of generic drugs. This role involves supervising laboratory personnel in routine finished product and stability testing, ensuring high standards of quality, and continuously improving laboratory processes and systems.

Responsibilities

• Supervise the testing of bulk release, finished product, and stability testing.
• Manage and supervise QC laboratory personnel, assigning work schedules and ensuring tasks are performed.
• Review test results for accuracy and proper documentation.
• Review specifications and Standard Test Methods (STMs) for in-process and finished products.
• Write Out-of-Specification (OOS) investigations, including root cause analysis and corrective/preventive actions.
• Supervise lab processes, including timely management of investigations and CAPA (Corrective and Preventive Actions) implementation to ensure sustainable compliance.
• Review SOPs, lab-related investigations, stability failure notifications, Certificates of Analysis (COAs), and compile stability-related data.
• Ensure timely release of in-process and finished product release COAs.
• Monitor and report trends in bulk, finished products, and stability samples to QC/QA Management.
• Review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new instruments, protocols, and reports.
• Coordinate with other departments such as warehouse, QA, Maintenance, Purchase, and R&D for daily operational requirements and cGMP compliance.
• Manage sample coordination, including in-process, finished product, and stability samples.
• Monitor Quality Control, Safety, and cGMP practices to ensure compliance with internal and external regulations.
• Perform other related duties as assigned to meet departmental and company objectives.

Management Responsibility: Manage a group of scientists. Reports to Associate Director / Director.

Requirements

• Minimum BA/BS in Biochemistry, Chemistry, or related field with 10-15 years’ experience in the biotech or pharmaceutical industry.
• Management experience in Quality Control required.
• MS/MA preferred.

Skills

• Ability to maintain integrity and honesty at all times.
• Strong communication and leadership with transparency.
• Accountable for performance and results of the department.
• Ability to assume additional responsibilities on own initiative.

Physical Requirements / Working Environment

• Regular laboratory environment requiring lab coats and safety glasses.
• Able to stand for 4-6 hours/day while performing chemical tests.

Pay

$100,000 - $120,000 per year.