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Ref: BBBH5073704_1487351184

QA Validation Associate

  • Cork
  • Not disclosed
  • Permanent full-time
  • Updated 17/02/2017
  • Sara O'Riordan
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Description

QA Validation Associate

 

QA Validation Associate

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, cleaning & steaming, computer systems, laboratory systems and changes to existing equipment/processes.


RESPONSIBILITIES

  • Provide project management oversight for validation activities related to BioMarin's products, process and cleaning validation activities.
  • Developing validation plans for specific system implementation projects.
  • Execute (protocol generation, execution, and final package preparation and reports) validation activities related to the implementation of process, cleaning, 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 by BioMarin, validation techniques/approaches and systems utilized at BioMarin
  • 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: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
  • Other duties as assigned

EDUCATION

  • Bachelor of Science degree, or higher, in a technical discipline ( physical, engineering, chemical or biological sciences) is required.


EXPERIENCE

  • 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process and cleaning 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 process and cleaning validation expectations.
  • Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.

Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Europe, Asia and Australia.

For more information and to see all the Engineering Jobs available go to http://www.berkley-group.com

To apply: If you would like to discuss this vacancy further or to discuss your career and other job options in confidence, please telephone Sarah O'Riordan on +353 (0)21 4289600 or send your CV to -group.com

Berkley Recruitment Group

Berkley Recruitment Group

 

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