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- Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
- Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
- Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
- Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
- Reviewing and approving of Validation/Qualification Documentation.
- Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
- Bachelor of Science, Engineering or related subject and 2 years of experience in validation, or
- Masters of Science, Engineering or related subject with 0 to 2 years of experience in validation
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and machine tool fundamentals.
- High level of PC skills.
- Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- Must be willing to work as part of a multi-site team, be able to travel as part of the job
- Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
- Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
- Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Highly developed problem solving and strong analytical skills.