QA Compliane Manager - Validation

Michael Bailey Associates - Zurich

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QA Compliane Manager - Validation

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.

Descriere companie

Detalii oferta de angajare

12 Jan 2019

Locatia jobului

Not Specified, Switzerland

Tip job

Project-based

Categorie job

Inginerie

Salariu lunar