Quality Control Manager (Solid Dosage experience required)

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

Job Summary

Supervise the work of laboratory personnel engaged in performing routine finished product testing & stability testing, including planning laboratory work, evaluating work performed and handling procedural and technical laboratory problems. Execute according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems

Job Duties & Responsibilities

• Supervise the testing of bulk release, finished product and stability testing
• Manage and supervise QC laboratory personnel with varying levels of experience, assigning the work schedule and ensure assigned tasks are performed.
• Review of test results for accuracy and proper documentation.
• Review of specifications and STMs for in process and finished products.
• Write OOS investigations, including finding root cause and corrective/preventive actions.
• Supervise lab processes, including timely management of investigations, CAPA implementation to ensure sustainable compliance
• Review of SOPs, lab related investigations, stability failure notifications, COAs, and compilation of stability related data. Responsible for timely release of in-process, finished product release COA’s
• Monitor and report the trends in bulk, finished products, and stability samples to QC/QA Management
• Review of IQ, OQ, and PQ for new instruments, protocols/reports
• Responsible for coordinating with other departments like warehouse, QA, Maintenance, purchase department, R&D in day to day activity for better operational requirements and to follow the cGMP requirements.
• Responsible for the coordination of sample management, not limited to in-process, finished product and stability samples.
• Monitor Quality Control, Safety and cGMP practices to assure compliance with internal and external regulations.
• Perform other related duties as assigned to meet departmental and Company objectives.

Management Responsibility

• Manage group of scientists.

Reports to

• Associate Director / Director