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Collins McNicholas Recruitment & HR Services Group

COMPUTER SOFTWARE VALIDATION ENGINEER

Collins McNicholas Recruitment & HR Services Group

  • Cork / Limerick / Nationwide
  • Negotiable
  • Contract
  • Updated 16/07/2012
  • Joann McGlinchey
this job is expired
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Description

COMPUTER SOFTWARE VALIDATION ENGINEER

 

Position Summary

Computer Software Validation Engineer will have primary responsibility for Quality Assurance activities associated with :-

-       Manufacturing Equipment/Automated Systems

-       Computer Systems

Key Areas of Responsibility

  • Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local Procedures as they relate to Computer Systems/Software Validation activities.
  • Participate on Divisional Validation Team to develop and revise Computer Systems/Software 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
  • Represent validation from a Computer Systems/Software Validation perspective 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.
  • Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.   
  • Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective 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 all Computer Systems/Software Validation Documentation.
  • Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
  • Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met.
  • Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.

 

Qualifications Knowledge Skills

  • A thorough working knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements.
  • Bachelor’s Degree in Science /Engineering is required.
  • Minimum of 3 to 4 years direct experience in a computer system/software validation role in either Medical device or Pharmaceutical Industry.
  • A thorough working knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements. 
  • High level of PC skills required.
  • The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Working Knowledge/experience of Risk Based Techniques.
  • Excellent communication skills and attention to detail.
  • An understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs an advantage.
  • Have a good understanding of engineering and machine tool fundamentals.
  • Source Code review experience a distinct advantage.
  • 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.

For additional information please contact Joann on 021-4809118 or email

Ref: CJ36882
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Collins McNicholas Recruitment & HR Services Group

Collins McNicholas Recruitment & HR Services Group

 

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