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CSV Manager
Eingestellt von Edelway
Gesuchte Skills: Support
Projektbeschreibung
CSV Manager
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Senior CSV Manager to join them on a long term basis.
Start Date: ASAP
Working language: English mandatory. German will be a plus.
1st assignment until the end of the year. Extensions for the right profile.
THE ROLE
-Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within EMEA
-Advisory and support of application owners to build and maintain GMP conform systems
-Support and consulting during projects handling GxP critical computer systems
-Approving specific computer system validation documentation and acting as software quality assurance
-Development, control and maintenance and of the CSV framework in EMEA
-Definition of the global CSV framework in collaboration with the regional CSV responsible from US and China
-Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
-Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
-Developing and performing CSV trainings
-Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
YOUR PROFILE
-5 years' experience in a similar position.
-Responsibility in similar management position or extended experience as executer required.
-Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, 11
-English is a must, German would be an advantage.
If it sounds like your next challenge, please send us your CV and we will contact you shortly to discuss it further.
Keywords: Pharma, Pharmaceutical, cGxP, cGMP, GAMP, cGAMP, Computer, Computerised, Computerized, Switzerland.
Edelway AG is a Swiss IT Services Consultancy. One of our best clients, a global multinational company based in the Bern area, is currently looking for a Senior CSV Manager to join them on a long term basis.
Start Date: ASAP
Working language: English mandatory. German will be a plus.
1st assignment until the end of the year. Extensions for the right profile.
THE ROLE
-Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within EMEA
-Advisory and support of application owners to build and maintain GMP conform systems
-Support and consulting during projects handling GxP critical computer systems
-Approving specific computer system validation documentation and acting as software quality assurance
-Development, control and maintenance and of the CSV framework in EMEA
-Definition of the global CSV framework in collaboration with the regional CSV responsible from US and China
-Approving change requests and monitor the necessary activities for the requalification/validation after changes, deviations, etc.
-Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
-Developing and performing CSV trainings
-Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
YOUR PROFILE
-5 years' experience in a similar position.
-Responsibility in similar management position or extended experience as executer required.
-Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, 11
-English is a must, German would be an advantage.
If it sounds like your next challenge, please send us your CV and we will contact you shortly to discuss it further.
Keywords: Pharma, Pharmaceutical, cGxP, cGMP, GAMP, cGAMP, Computer, Computerised, Computerized, Switzerland.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges