Dishman Carbogen Amcis - Manager - API Quality Control

Position Summary:

- Dishman Carbogen Amcis Limited is looking for an experienced and detail-oriented Manager - API QC to lead the Quality Control function for its Active Pharmaceutical Ingredient (API) operations. The ideal candidate will have a strong background in QMS, investigations, stability studies, GLP, and instrument calibration, with a solid understanding of regulatory and compliance requirements.

- This role is critical in ensuring the consistent quality of APIs manufactured at the Bavla facility, supporting global regulatory standards.

Key Responsibilities:

Quality Control Operations:

- Oversee and manage the QC activities related to API testing, including raw materials, intermediates, finished products, and stability samples.

- Ensure all laboratory operations are performed in compliance with GLP, GMP, and internal quality standards.

- Monitor and maintain adherence to batch release timelines through effective planning and resource allocation.

Quality Management System (QMS):

- Lead QMS-related activities such as deviation management, out-of-specification (OOS) investigations, change controls, and CAPA implementation.

- Ensure timely and thorough investigation of non-conformances and implement preventive measures to avoid recurrence.

Stability Studies:

- Supervise the design, execution, and review of stability studies for APIs in compliance with ICH guidelines.

- Ensure accurate and timely reporting of stability data and trend analysis to support product shelf-life and regulatory submissions.

GLP Compliance:

- Enforce adherence to Good Laboratory Practices in all QC operations.

- Ensure data integrity, proper documentation practices, and continuous compliance with applicable regulatory standards.

Instrument Calibration & Maintenance:

- Oversee the calibration, qualification, and preventive maintenance of analytical instruments (e.g., HPLC, GC, UV, IR, KF).

- Ensure that all equipment is validated and functioning optimally to support accurate and reliable testing results.