QA Validation Specialist (Sustainability)

  • Cork
  • Contract 12 months
  • JO-1908-64700_1565778082

Summary

A Validation Engineer (Sustainability)

This position is responsible for the execution, project management, review and approval of validation activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.

Responsibilities:

  • Provide quality and project management oversight for review and approval of Qualification and Validation of Facilities, Utilities & Equipment (FUE) activities related to company's products. Project lifecycle documentation e.g. URS, Commissioning/ Qualification Protocols, GMP Risk Assessments, Design Specifications, Functional Specifications, Installation Qualification, Operational Qualification, Performance Qualification, respective protocols and reports, supporting site discrepancies/deviations, investigation and closure in line with company quality standard and site procedures, etc.
  • Responsible for delivering the Revalidation program (RVE) requirements as per the RVE schedule.
  • Coordinate and communicate revalidation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, etc.
  • RVE responsibilities include the following: performance of detailed system review, generation of RVE documentation, scheduling & coordination of each RVE, performing and/or coordinating revalidation testing, completion of validation documents, etc.
  • Assess the impact of changes to the validated state of systems/equipment as part of the site change control program (e.g. system implementation projects /system modifications, etc.) and Trackwise deviations. Demonstrate a robust understanding of Change Control process; appreciating wider implications to site beyond immediate requirement
  • Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks
  • Maintain current knowledge of industry standards and regulatory requirements and trends for products developed or manufactured by the company, validation techniques/approaches and systems utilized.
  • Lead and represent validation in multi-departmental meetings & project teams.
  • Identify and implement improvements to the QA Validation systems.
  • Demonstrate the ability to exercising judgment within broadly defined procedures and practices to establish approval criteria and identify and implement solutions.

Requirements:

  • Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of Facility, Equipment and Utility validation and Laboratory Systems validation.
  • Experience in a number of the following areas would be desirable: Cleaning Validation, Sterilisation, Temperature Mapping, Packaging Validation, etc. Computer Systems Validation experience would be an advantage.
  • Organizational and management skills to coordinate multi-discipline project groups
  • Demonstrated ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Demonstrated ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
  • Proficiency in use of risk assessment and problem-solving tools to contribute, as a technical resource, to Quality / Compliance-related investigations.
  • Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.

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