Analysis of In process, Finish Product and Process validation samples as per defined procedures.

Taking part in Investigation of OOS & OOT.

-Compliance to Regulatory Guidelines (21 CFR Part-11, WHO, ANVISA, TGA and

Schedule M)

-Handling of Regulatory Audits (Preparation, Execution and Response)

-Risk Assessment and HACCP implementation

-Coordination with CQA/Regulatory Agencies.

-Review and implementation of stability procedures & Protocols.

-Handling of Regulatory Audits, Customers and Certification Bodies (Execution and Response)

-Supplier Audit and compliance monitoring. - Imparting trainings to the personnel and evaluating their skills.

-Implementation of Improvement projects (i.e. Reduction of Laboratory Errors to

reduce OOS, OOT and Incidents, Reduction of Solvent Consumption, Harmonization

and simplification of procedures).

📌 Manager (Sambhajinagar)
🏢 Glenmark Pharmaceuticals
📍 Sambhajinagar