Validation Deviation Lead

Cork  ‐ Onsite
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Description

RESPONSIBILITIES:
  • Support plant, process and software validation review and deviation activities in a Medical Device regulated environment
  • Identify deviations from established product or process standards and provide recommendations for resolving
  • Analyse validation test data to determine whether systems or processes have met validation. Help resolve problems encountered during validation.
  • Ensure Consistency in validation/qualification approach across systems and projects.
  • Provide guidance and direction in the completion of validation activities.
  • Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
  • Conduct Periodic Reviews of validation performance and make recommendations to improve and streamline the process
  • Ensure correct use and review of the change control process in relation to Validation requirements
  • Help determine process capability of new equipment


ESSENTIAL SKILLS AND EXPERIENCE:
  • Degree Educated in relevant Science or Engineering discipline
  • Minimum of 4 years Quality Assurance / Regulatory affairs experience
  • Experience in working within a Medical Device Manufacturing Environment.
  • Six sigma Green or Black Belt Certified
  • Experience in completing Process Validation's as per CDRH Guidance
  • Experience in using Gamp 4 or Gamp 5 Software V and V Techniques
  • Sound understanding and utilization of Problem Solving Techniques
  • Good computer skills (MS Word, Power-point and Excel)
  • Experience writing standard operating procedures, training documents, and regulatory responses.
  • Experience in statistical Analysis / MSA / DOE / DMAIC and problem solving methods.
  • Experience writing test plans, project plans, procedures and project schedules.
  • Experience reviewing Functional Requirements, Design Specifications, FAT's, SAT's, IQ's, OQ's, PQ's.
  • Knowledge of cGMP, Cleaning, Process and Product Validation requirements and techniques.
Start date
08/2015
Duration
12 months
From
Real Staffing
Published at
29.07.2015
Project ID:
955119
Contract type
Freelance
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