Job Purpose :
To ensure that site in compliance with all the regulatory & GSK requirements for effective Documentation process and timely transfer in Controlled Document Management System at site.
Assist Quality and Head of Quality with respect to quality and regulatory compliance at site.
Technical documentation support provide to Production, Warehouse, Logistic, Procurement, Engineering, EHS, Technical and Quality.
Key Responsibilities :
Management of all technical compendiums (i.e. Primary and Packaging Compendium, Analytical Procedures, Delivery system), Master technical dossiers, Manufacturing and control documents and manuals and securely handles and maintain records.
Preparation of SOPs, IFS, Test Methods, Generate / edit documents in CDMS (Controlled Document Management) and maintain the record
ABAC (Anti-Bribery and Corruption) record and register handled and maintained, for any information about interactions with Government Officials visits via log by collecting and processing Personally Identifiable Information (PII) and comply with the requirements
Handle Regulatory queries and correspondence, Sealed Warrantors samples portions for physical inspection. Keep all the Govt.
records along with sealed samples and keeping samples at the time requirement.
Procurement of Reference standards from Group for Analytical and Micro Lab for testing on time
Prepare and generate Certificate of analysis of product batches manufactured at site, raw materials and Reference standards.
Handling of all Ministry of Health correspondence and samples received from Regulatory and Legal Department appropriately with notification and deliver to the Compliance Manager for necessary actions.
Ensure QMS & EHS requirement as per the applicable SOPs.
Weekly / Monthly reporting of Quality activities and support for Site Quality Council meetings and daily maintenance of attendance and annual leaves.
Other Job Skills :
Management skills - coordination across multi function team i.e. Warehouse / Production / Engineering for technical documentation management
Required Education :
Business / Computer Science Graduate with good computer skills
Required Experience : 2-3 years
Contact information :
You may apply for this position online by selecting the Apply now button.
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