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Job Details

Associate Director of Release & Compliance

Company: Edelway Switzerland AG
Location: Zurich area, Bern
Reference: A-001
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

*

Requirements:

Our global pharmaceutical Client is now looking to hire on a permanent basis its Associate Director of Batch Release and Compliance to join them in Zurich / Bern area.

You will lead the implementation of a new biotech site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations.

You will have the overall responsibility to ensure the requirements of the Quality System Regulations is established and will be the Responsible Person role for the site which will rely on execution systems such as Delta V, Syncade, Infor10, KNEAT, Labware LIMS and Oracle, and PAT for the control strategy.

You will ensure that the site is GMP ready as per project schedule, including but is not limited to: batch release (responsible person), maintaining Site Master File, Quality point of contact for technology transfer, responsible for site management review, host of audits and inspections, point of contact for corporate quality functions (internal and external auditing, regulatory intelligence, documentation control, training, exception and CAPA management.

Locations: Switzerland, Zurich / Bern area

Start: ASAP

Salary:  excellent

YOUR ROLE

  • Design and Manage the Release and Compliance Team of subject matter experts who themselves are responsible for specific functions according to job descriptions.
  • Drive activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production on site.
  • Design, review and maintain quality plan to ensure site GMP readiness as per project timeline.
  • Represent the Site Quality within the global quality organization.
  • Be the Quality lead and Responsible Person for batch release & compliance.
  • Ensure site training plan and system for content / documentation are in place and maintained.

YOUR PROFILE

  • 10 plus years’ experience in pharmaceutical or biotech manufacturing environment.
  • Prior experience with facility construction preferred.
  • Proficiency with the Quality systems and business processes associated with automation and integration of testing and production systems.
  • Risk management
  • Leadership skills in a matrix organization.
  • Experience in drug substance (or API) and drug product.
  • Deep experience with quality systems in a paperless biologics environment.
  • Experience with LEAN, Six Sigma and continuous improvements.
  • Willingness to travel up to 30 % during the first two years of employment then periodically.
  • English fluent. German is a plus.

 

If this sounds like your next challenge could you please send me your updated CV in English at alexis@edelway.com (+41 58 717 7035) and I will call you to discuss it in more details.

Apply for this job: Associate Director of Release & Compliance

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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