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QA Compliance Specialist

Switzerland, Switzerland

  • Salary: Dependent on Experience
  • Job type: Interim/Contract
  • Posted: 30/11/2018
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 3833

Job description

1 Year contract


Accountabilities:
• Supports project activities as member of QA Compliance for activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities
o Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
o Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
o Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations
o Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
• Supports project activities as member of QA Compliance for activities related to Quality Management System
o 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)
o Prepares training modules for QA Compliance
• 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).
• 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.