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Digital Process Specialist at GSK plc - ApplyBlast

Digital Process Specialist

GSK plc

3 months ago

4.2 on Glassdoor

Upper Merion, Pennsylvania

Onsite

Full Time

Senior

0 applicants

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About this role

This role leads the strategy for digital batch records using the Mendix Clinical Batch Record (CBR) system at GSK's US biopharm pilot plants. The incumbent acts as a subject matter expert to drive the digitization of manufacturing, ensuring compliance with cGMP requirements while collaborating with global teams on system enhancements and technology transfers. Key duties include overseeing batch record development, troubleshooting production issues, and authoring technical documentation for regulatory filings.

Responsibilities

Lead strategy for digital batch record implementation across US pilot plants
Drive training strategies and provide guidance to pilot plant staff
Collaborate with stakeholders to gather feedback and deliver successful designs
Troubleshoot production issues to ensure technical success of biopharma campaigns
Author manufacturing sections of regulatory submissions for health authorities