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QA ecompliance Expert CSV

Entreprise
GlaxoSmithKline Plc Switzerland
Lieu
Vaud (La Côte)
Date de publication
17.03.2017
Référence
288152

Description

QA eCompliance Expert CSV

Purpose of the Role

Coordinate QA e-Compliances activities for computerized systems within Nyon Plant

Main Responsibilities:

  • Is responsible for the full execution of the annual plan. Manage several CSV projects as once

  • Review and approve all computerized systems key validation deliverables and major changes for systems as QA representative

  • Review and approve change requests of GxP validated computerized systems. Investigate deviations and define appropriate corrective and preventive actions to avoid re occurrence

  • Drive and provide internal CSV training of Systems Owners and Project Managers

  • Maintain and make approved local CSV procedures

  • Lead and support inspection related to e-Compliance

  • Plan and conduct assigned vendor audits of computerized system and computerized or service suppliers.

 

Profile:

  • Bachelor of Sciences in Engineering, Engineer of Pharmacist preferred. Pharmacy, Chemistry, Information Technology with several years (> 3) of experience in technical project management with proficiency in English. Pharmaceutical or related regulated industry will be a must

  • Minimum 3 years’ experience in a Pharmaceutical Quality Environment. Industrial Processes : level 3 / GMP (GAMP 5 & 21CFR Part11) : level 3 / IT: level 3 / Quality Systems : level 3

  • Experience in the industry in the field of project management with experience in Quality management, IT compliance, or equivalent.

  • Ability to demonstrate leadership

  • Ability to demonstrate proficiency and thorough knowledge of computerize systems requirement defined by applicable European & US legislations, Health authorities and/or industry groups



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