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Quality/Compliance Consultant - GxP - Pharma - Switzerland - Contract
Eingestellt von Coopers Group GmbH
Gesuchte Skills: Consultant, Natural, Client, Erp
Projektbeschreibung
QUALITY/COMPLIANCE CONSULTANT required to work on a project for a major pharmaceutical in Switzerland
MAIN TASKS:
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Ensure that all GxP Computerized Systems comply with the requirements of the Client Corporate Quality Manual and meet all relevant GxP regulatory requirements throughout the systems life cycle.
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Specifically
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Ensure that Data Integrity is maintained throughout the business process.
-
Ensure that programming and validation procedures comply to the requirements of the Clients Corporate Quality Manual.
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Review, evaluation, and approval of Computerized System related quality concepts, plans and documents of divisional and local projects and applications.
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Oversee QA operations for computerized systems validations and change control.
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Review/approve validation deliverables for global computerized systems in the QA role.
MAIN SKILLS:
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Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry
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German and English fluent in speaking/writing
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Experience in GxP regulated Pharmaceutical Industry (eg in Quality Assurance), IT departments, Quality Management Departments or equivalent Consultant positions with excellent knowledge of computerized system validation aspects and 21 CFR Part 11/EU Annex 11 requirements.
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Good experience with Quality Management and Computerized Systems Validation aspects of application implementations and operations (eg Clinical Data Management Systems, ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
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Knowledge in scientific and clinical data management and statistical programming is an advantage
LOCATION: BASEL - SWITZERLAND
DURATION: ASAP - 30. September 2014
HOURLY RATE: negotiable
Assistance will be provided for obtaining Swiss Work Permit, Housing, and opening Swiss Bank account.
"COOPERS" - We dedicate our best efforts to make your stay comfortable.
MAIN TASKS:
-
Ensure that all GxP Computerized Systems comply with the requirements of the Client Corporate Quality Manual and meet all relevant GxP regulatory requirements throughout the systems life cycle.
-
Specifically
-
Ensure that Data Integrity is maintained throughout the business process.
-
Ensure that programming and validation procedures comply to the requirements of the Clients Corporate Quality Manual.
-
Review, evaluation, and approval of Computerized System related quality concepts, plans and documents of divisional and local projects and applications.
-
Oversee QA operations for computerized systems validations and change control.
-
Review/approve validation deliverables for global computerized systems in the QA role.
MAIN SKILLS:
-
Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry
-
German and English fluent in speaking/writing
-
Experience in GxP regulated Pharmaceutical Industry (eg in Quality Assurance), IT departments, Quality Management Departments or equivalent Consultant positions with excellent knowledge of computerized system validation aspects and 21 CFR Part 11/EU Annex 11 requirements.
-
Good experience with Quality Management and Computerized Systems Validation aspects of application implementations and operations (eg Clinical Data Management Systems, ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
-
Knowledge in scientific and clinical data management and statistical programming is an advantage
LOCATION: BASEL - SWITZERLAND
DURATION: ASAP - 30. September 2014
HOURLY RATE: negotiable
Assistance will be provided for obtaining Swiss Work Permit, Housing, and opening Swiss Bank account.
"COOPERS" - We dedicate our best efforts to make your stay comfortable.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Organisation/Management