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).

Disclaimer: This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager (Sambhajinagar)
🏢 Glenmark Pharmaceuticals
📍 Sambhajinagar