Validation /Compliance Expert – sterile manufacturing

Sector:
Farmaceutica
Currency:
CHF
Locatie:
Zwitserland
Salaris Omschrijving:
excellent
Gepost:
02/07/2019
Job Ref:
123551

Daily tasks:

Supports project activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities
Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
Review and approve Cleaning 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
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
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



Candidate profile:

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

Prior experience in validation and qualification of equipment

Prior experience in quality assurance and compliance tasks

Excellent knowledge of GMP regulations

Excellent knowledge of German and English languages

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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