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Job Details

Quality Automation Manager – Pharma

Company: Edelway Switzerland AG
Location:
Reference: A-006
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Edelway is a Swiss IT/Engineering professional recruitment company.

Requirements:

Our global Pharmaceuticall Client is now looking to hire on a permanent basis its Quality Automation Manager to join them in Zurich / Bern area.

You will support the setup and structure of the automation and MES systems (Delta V - Syncade) to enable the start-up, commissioning and validation of a new manufacturing facility with a fully integrated electronic batch record.

You will review/approve automation validation and engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where quality assurance needs to approve before implementation and upon completion.

You will also be involved in the creation and implementation of systems which govern the validation and change control of the automation and MES systems being implemented.

Fluent English is required, German is a plus.

Locations: Switzerland, Zurich/Bern area

Start: ASAP

Salary: excellent

YOUR ROLE

  • Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) related to automation and MES systems (Delta V, Syncade, etc.)
  • Provide support on projects across sites requiring a good working knowledge of regulatory, procss systems and automation/MES systems.
  • Work with the quality engineering team and stakeholders to revise/develop and implement complex quality systems in a global scope.
  • Ensure adherence to internal procedures for facility/equipment and automation controls during and after production operations.
  • Performs quality review and approval of change control documents and activities associated with change control.

YOUR PROFILE

  • 10 years of experience in pharmaceutical/biotech environment.
  • BSc in Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science.
  • Experience within Quality Assurance, Validation, Automation/MES or related function.
  • Knowledge of GAMP and applicable automation regulatory knowledge and FDA regulatory.
  • Fluent English. German 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.

Alternatively if you think this position could benefit someone you know, please do not hesitate to forward it and cc.

Apply for this job: Quality Automation Manager – Pharma

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

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

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