CSV Manager

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

CSV Managers& Senior Consultants

Long Term Contract

Solothurn, Switzerland

Salary: Negotiable

Our client is seeking experienced CSV Professionals to join their team on site in Solothurn assisting with planning and implementation of validation projects they are currently undertaking

Tasks:

- 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 responsiblefrom 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.).

Requirements:

Responsility 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 CFRPart 820, Part 11

Our client is looking for Consultants with approx 5 yrs experience, English is a must, German would be an advantage.

Please email
Start
04/2013
Dauer
9 months
Von
Berry Technical
Eingestellt
12.03.2013
Projekt-ID:
502896
Vertragsart
Freiberuflich
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