Description du poste
Your Role:
Part of the global QHSE team, you are responsible to oversee and perform computer systems validation activities for global systems, ensuring that business processes required to operate are qualified and maintained in a validated state according to company directive and procedures.
You work with members of I.T., Quality Assurance, and other stakeholders to ensure that computerized system validation files are consistent.
You are the primary point of contact for the business to define and scope of global CSV projects and testing strategy based on risk.
What are you going to do?
Main areas of focus and accountability of the role – detail in order of importance the main areas of accountability of the role:
COMPLIANCE :
- IT CSV oversight for GXP computerized systems.
- Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, GAMP 5).
- Provide validation strategy to the introduction of computerized systems.
- Handling deviations, CAPAs, and change controls related to scope of function activity.
DOCUMENTATION AND REVIEW :
- Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and validation reports
- Ensure Computerized Systems are appropriately qualified and validated while conducting review of related documentation and leading quality risk assessment and change management activities.
- Lead and execute validation activities that are identified and required.
- Prepare all the documentation associated by ensuring the execution following the plan.
- Ensure that all validation activities are carried out and reported in a timely manner.
- Ensure that all deviations during validation activities are investigated and escalated when required.
- Propose action plans and ensure that correctives/preventives actions are followed and closed on time.
- For Local Computerized Systems support review user, functional and technical specifications.
- Develop test plans, coordinate and supervise testing phases and manage issues.
- Review test scripts for functional testing, regression testing and load testing.
VALIDATION SUSTAINABILITY :
- Organize and lead activities include but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ/OQ/PQ), Data Migration, SOPs and Change controls
- Conduct validation training with project team communicating deliverables, procedures and methods whilst supporting the department training / education program by coaching and mentoring of new and existing employees. Provide education and training on CSV related topics to areas of the business with specific requirements.
- Represent the company to clients (internal and external) and Regulatory authorities as a CSV Lead.
CHANGE MANAGEMENT :
- Lead and coordinate change management process related to CSV and ensure validated state of systems is maintained.
- Coordinate Risk Assessment for system changes.
Travel in France to be plannes once a month depending on the location of the position.
Description du profil :
Who are we looking for?
- Bac+5 Qualification in Computer Science or equivalent.
- More than 8 years’ experience in Healthcare CSV.
- Experience of managing documentation relative to qualification and validation in compliance with quality structure.
- Experienced in establishing the procedures, policies and masterplans that define a CSV and revalidation program.
- Strong knowledge of GXP regulations related to CSV including 21 CFR par 11, EU GMP annex 11, GAMP 5.
- Knowledge of computerized system development life cycle approach.
- Ability to work in cross-functional team environments as well as independently and have the flexibility to adapt to changing priorities.
- Demonstrated mentoring of others and the ability to directly influence cross functional teams
- Good communication skills.
- Drive for Results / Action oriented / Decision Maker / Customer focus / Motivating Others
- Capability to communicate at all levels in the organization
- Mandatory: Fluent english
Global Computerized System Validation Expert