Philip Morris - CSV Engineer
For our client Philip Morris SA in Neuchâtel, we are seeking an :
CSV Engineer : Computer system validation
Initiale duration : 6 months
Lead computerized system validation project approach. Participation in
the establishment of validation strategy of computerized system and QA
review all documentation produced by the project SME. Maintain and insure proper validation state of system within his scope of competency. Ensure training of project team members and users of the system regarding validation and data integrity. Insure that projects plan and change management activities are properly scheduled and are adequately staffed.
- Participate in the creation and maintenance of the risk assessments (Project and Change) Validation Plan and Validation Report of new and existing system.
- Ensure that all validation activities are carried out, reported and closed according to plan provided by the Validation Lead.
- Perform QA Review of SME documentation produced to support the system validation.
- Participate in the development and improvement of QMS procedures and practices for data integrity and CSV as it relates to the area of responsibility.
- Advice project manager and service manager for validation activities and workload to ensure proper planning and workforce mobilization to perform the activities.
- Train and coach on the validation and data integrity strategy and practices as well as practices related to CSV and data integrity.
- College, University : Technology, science, engineering or equivalent
Work eperience :
- 5-10 years of experience in computerized system activities or validation activities. IS and business experience would be an asset. Experience in computerized system validation (CSV/GAMP5) would be an asset.
- You can use this field to describe any skills required for this job
- Experience in the CSV for the area
- Experience in Ability to deal with external suppliers and third party
- Soft skills:
- Communication, negotiation, ability to coach, Business acumen,deal with ambiguity, managerial courage, result oriented, project management
- English - Fluent or morther tongue
- French - Would be an asset