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QA CSV Compliance Manager

QA CSV Compliance Manager

LocationBasel, Switzerland
Business SectorBiotechnology
Contact nameAliyana Darwesh
Contact email
Job ref22375
Published2 months ago
QA CSV Compliance Manager

Currently working with a Global Biotech Client who are in need of support from a QA CSV Compliance Manager (GxP) for high-level projects in Switzerland. This is an opportunity to work with an industry-leading organisation with ground breaking technology for a 12-month contract (extension expected).
 
Interview + offer will take place this week and next, so get in touch ASAP if interested.

Responsibilities:
 
  • Review and approve quality-related documentation, including SOPs, specifications, validation/qualification documents, periodic reviews, change requests, CAPAs, deviations, etc.
  • Provide QA project support for computerized systems, data transfer, and IT-related topics.
  • Drive and take responsibility for improvement projects as applicable to enhance overall system efficiency and compliance.
  • Contribute to the ongoing maintenance and optimization of routines for computerized systems, including updating templates, system lists, VMP, and overseeing periodic reviews.
  • Play a key role in the ongoing maintenance and optimization of the organisation's Quality System.

Requirements:
 
  • Engineering degree or Master's degree in IT or Life Science
  • 5+ years of hands-on experience in a Quality role within a GxP environment.
  • Previous experience as a QA specialist for computerized systems, validation/system responsibility, or a quality role within IS/IT.
  • In-depth knowledge of regulations and guidelines e.g. CFR Part 11, EU GMP VOLUME 4 (Annex 11), Data Integrity, and GAMP.
  • Familiarity with Auditor training and/or supplier management is considered an asset 
  • Ability to work independently with an ambitious mindset, demonstrating proactive and service-oriented attributes.
  • Professional proficiency in English.

Position: QA CSV Compliance Manager
Location: Basel, Switzerland
Start Date: Immediately or by agreement
 

For more information, contact Aliyana Darwesh

? +41 44 5514 407

? a.darwesh@panda-int.com