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Quality Assurance Specialist

Eingestellt von Edelway

Gesuchte Skills: Support, Sap

Projektbeschreibung

Quality Assurance Specialist - English & German

Edelway is a Swiss Professional Services Consultancy. One of our best clients, a global pharmaceutical company based in the Zürich area, is currently looking for an experienced Quality Assurance specialist to join them on a long term basis.

Working language: Fluent English & German
Start Date: ASAP - Within 1 month from offer
Length of the assignment: 1 year. Extensions for the right profile.

THE ROLE
*Qualification of 3rd party suppliers (contract manufacturing organization, CMO) in EMEA who will receive ca. 10 API's from our client in an outsourcing project
*QA review & approval of tech transfer documents
*QA support for process and method implementation at CMO
*QA review of validation documents and "on-site" supporting during validation campaign
*QA review and approval of executed batch records/manage delegation for batch record review
*Execution of CMO qualification, ie audits, quality agreements, specification agreements, qualification statements, etc.
*Monitoring of qualified CMO

YOU NEED
*University degree in a life science discipline, eg Chemistry, Pharmacy, Microbiology
*4 years experience in pharmaceutical industry (production and/or quality department, laboratory or R&D)
*Experience in managing external manufacturers
*In depth knowledge of cGMPs in EU and US and ICH-regulations
*Ideally 1-2 years experience as an auditor in pharmaceutical industry
*Ability to work in a global Matrix environment
*Fluent in English and German language
*Knowledge of IT applications, eg MS Office and ideally SAP/Trackwise
*Some flexibility in working hours is required
*Able to follow change management

If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it in more details.

Projektdetails

  • Einsatzort:

    Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    1 Year. / Long Term

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    SAP Entwicklung, Sonstiges

  • Skills:

    support, sap

Edelway

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