General Manager - Quality Control - Active Pharmaceutical Ingredients

- To ensure compliance to quality systems and GMP requirements in the laboratory.

- To review the Quality Control related documents such as Specifications STPs Protocols and ensure compliance w.r.t. regulatory requirements.

- To review procedures impacting quality of products and ensuring the implementation of SOPs for QC Department at Site.

- To ensure compliance w.r.t qualification of working standard procurement and inventory management of reference standard and impurity standards.

- To review and approve all quality related documents related to QC.

- To plan and facilitate team working to ensure Testing/ Analysis TAT is achieved for RM, IN-Process, Intermediates, Stability Study and Finished API.

- Responsible for release and rejection of all Intermediates and Raw Materials.

- Approve specifications, Method Analysis, Testing procedures, Protocols and Reports.

- To review change control, deviations and ensure critical/major incidents are investigated and resolved as per GMP guidelines.

- Address Market Complaints, Investigate and implement CAPA related to laboratory testing.

- Ensure investigation of OOS/OOT and implementation of CAPA related to Phase I Lab investigation.

- To conduct Internal Audit (Self Inspection) in Lab and ensure CAPA implementation.

- Support RA for DMF submissions and plan the QA activities as per regulatory requirements.

- Coordinate with R&D/PRD/Production/QA/TT for technology/analytical transfer activities.

- To take effective measures for cost controls and optimization of resources.