Compliance Expert

Quanta Consultancy Services Ltd
United Kingdom
£80 - £100 per hour, Benefits: Excellent Package o
06 Oct 2017
08 Nov 2017
Contract Type
Full Time
Client Overview My client is one of the largest Asian biopharmaceutical organisations on the planet with an excellent portfolio of products that are distributed across all continents. Reason For Hire: The greenfield facility is currently beginning their construction phase, however the client wish to keep technical knowledge within the company. Therefore the Quality Director for the project has asked Quanta to provide QA Compliance Experts to oversee and advise the team on best practice for compliance with USFDA/EMEA regulations. Tasks: - Support project by taking ownership of documentation compliance. - Review, update and implement project compliance across equipment, methods, documents & other business areas (production, design, quality, engineering). - Change Control / Deviation management, FAT / SAT execution, Qualification plan / report review. Creation of master templates for performance qualification templates. - Review and gap check of certain key documents like; - CQ Master Plan - Regulatory Affair documentation - Qualification Templates - Site Layouts (Piping flows, classifications & various room pressures of the plant) - Challenge internal SMEs on their existing processes and suggest improvements. Must Have Experience: - QA background - CQV Background - Senior QA experience within FDA regulated environment - Biopharmaceutical experience is key For further infromation, please get in contact with Kasim via [Phone number removed] / [Email address removed] .
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