Description
I have an immediate opening for a Quality Validation Engineer with a leading medical device company based in Cork. This is a great opportunity to join one of the most respected medical device companies globally.As process owner, you will be responsible to drive and implement process improvements to ensure optimised validation processes:
* Have in-depth knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
* Participate on Divisional Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
* Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures.
* Lead implementation of Corporate Validation changes as required.
* Represent validation at both internal and external audits.
* Ensure that QE's and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
* Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
* Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
* Review/Approval of Validation/Qualification Documentation.
* Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
* Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
* Build quality into all aspects of validation by maintaining compliance to all quality related requirements.
* All other duties as assigned.
Qualifications:
Bachelor's Degree in Science /Engineering is required.
* Minimum of 3-5 years direct experience in a Validation Role in either Medical device or Pharmaceutical Industry.
* High level of PC skills required. The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
* 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.
* Excellent communication skills and attention to detail.
* Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
* Have a good understanding of engineering and machine tool fundamentals.
* Lean Six Sigma training a distinct advantage.
* Must be willing to work as part of a multi-site team.
If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan for immediate consideration.