CSV Engineer Consultant
Our client, a medical device company requires a CSV Engineer Consultant for a 12 month Consultancy role in Germany.
Main Duties & Responsibilities
- Responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.
- Develop a process for the validation of computer systems ensuring compliance to required regulatory requirements.
- Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
- Keeps systems and processes developed for computer and automation systems validation up to date and compliant.
- Gives guidance on all activities related to computer and automation systems validation.
- Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
- Compiles and analyses validation data and makes recommendations for changes and/or improvements.
- Maintains all documentation pertaining to computer systems validation.
- Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
- Coordinates assigned projects and represents department on project teams.
- Serves as an information resource for computer systems validation to validation engineers, contractors and vendors.
Educational / Professional Details Required
- Min 3 years of experience in CSV system development life cycle is required.
- Excellent verbal and written communication skills with a demonstrated capability to communicate to external stakeholders
- Strong decision making and problem solving skills
- Demonstrated ability to plan and complete tasks to a defined timeline.
- Excellent Planning & Organizing Skills
- Strong knowledge of system development life cycle is required.
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