Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
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.
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
Geforderte Qualifikationen
-
Kategorie:
SAP Entwicklung, Sonstiges