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QA Compliance Manager

QA Compliance Specialist (m/f)

Start: as soon as possible

Duration: 6 months with possibility of extension

Remote: no

Location: Schaffhausen area

For one of my biggest pharma clients I am currently looking for a QA Compliance Specialist with the following skills set.

Accountabilities:

  • Supports project activities as member ofQA Compliance for activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities
    • Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
    • Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
    • Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
    • Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations
  • Supports project activities as member of QA Compliance for activities related to Quality Management System
    • Writes / Reviews / Approves SOPs/Forms/reports associated with above duties and provide support for creation, maintenance and retirement of GMP related documentation in the respective databases (e.g. Sharepoint)
    • Prepares training modules for QA Compliance and C&G
  • Adheres to HSE guidelines and requirements

Candidate profile:

Education: (minimum/ desirable):

  • A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.

Language:

Relevant Experiences:

* Professional in German and English (spoken and written).

Skills set:

  • Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry (sterile / biotechnology / C&GT a plus) or comparable experience in other industries.

If you are interested in this position please send me your CV to k.blomberg (at) realstaffing.com and give me a call on +41 (0) 44 588 2636.

Looking forward to your application.

Kaja

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.