Compliance Expert

Only English-written CV will be accepted.

Please note that only selected candidates will be contacted.

For our Client in STEIN, we are looking for a COMPLIANCE EXPERT, for a minimum 7 MONTHS contract.

Duration: 01/06/2018 - 31/12/2018

LOCATION: STEIN, AG,SWITZERLAND

Workload: 100%

Major Responsibilities:

- Review and approval of Equipment, Facility and Utilities Qualification Protocols and Reports including associated Risk Assessments and Deviations (on paper and/or in COMOS)
- Review and approval of Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers, Computer System Validations and Filter Validations) including associated Risk Assessments and Deviations.
- Review and approval of technical changes (act as QA Gate Approver in Agile PLM ACC).
- Support and perform review and release of manufacturing lines after maintenances (planned and unplanned).
- Review and approval of other documents within the scope of the department (eg Ongoing Process Verification, Shipping Verifications, Leachable/Extractable reports, etc.).
- Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable.

Candidate's Profile:

Work experience:

- Documented track record for activities in a QA function.
- Documented track record in plant qualification in sterile field (filling) and non-sterile field (packaging)
- Professional experience in Quality Control/Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology
- Profound knowledge of cGMPs

Education:

- (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- Post graduate diploma in business administration or equivalent

Linguistic background:

German/English spoken and written

For further details please contact Aleksandra Sztajerowska: 
(see below)

Legal Statement

By sending the application you authorize Harvey Nash AG, Badenerstrasse 15, Postfach, CH - 8004 Zurich for processing your personal data included in your job application for the needs of the recruitment process and the future recruitment processes. You also express the consent to sending your personal data to any other entity of Harvey Nash group for recruitment purposes.