QA Compliane Manager- Validation

Sector:
Farmaceutica
Currency:
CHF
Locatie:
Zwitserland
Salaris Omschrijving:
excellent
Gepost:
11/01/2019
Job Ref:
122229

We have a new opportunity or an experienced quality assurance expert to support a busy team with QA compliance activities related to qualification and validation of equipment.

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
o Prepares training modules for QA Compliance and C> Stein
• Adheres to HSE guidelines and requirements

Candidate profile:
Education: (minimum/ desirable):
• A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent. • Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry (sterile / biotechnology / C> a plus) or comparable experience in other industries.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Contactgegevens:
Tel: 020 7739 2022
Contact: Beata Klecz
E-mail:

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