JOB DETAILS
LOCATION
Cork
POSTED
30+ days ago

Description

:

PM Group now wishes to recruit a QA Validation Engineer for a pharmaceutical client in Cork. The QA Validation Engineer will have a high level of initiative, energy and motivation are key role requirements, as well as organizational skills.

This position is responsible for the execution, 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.

:
  • Provide project management oversight for FUE activities related to products and facilities, utilities, equipment (FUE)
  • Developing validation plans for specific system implementation projects
  • Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment     changes while exercising judgment within broadly defined procedures and practices to establish approval criteria and identify and implement solutions
  • Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured on site, validation techniques/approaches and systems utilized
  • Lead and represent Validation in multi-departmental meetings & project teams
  • Identifies and implements improvements to the QA Validation systems
  • Participation in the change control program for modifications to qualified systems
  • Coordinate validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others
  • Other duties as assigned

 

:
  • +5 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation
  • Organizational and management skills to coordinate multi-discipline project groups
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors
  • 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 with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred
Source: PM Group