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Senior QA/Validation Engineer

Job Description

Overview

PM Group is an international project delivery company operating across Europe, the USA and Asia. We have 47 years track record in project management, process design, facility design and construction management for leading multinational companies.  We are world leaders in the pharmaceutical, food, mission critical, medtech, advanced manufacturing and energy sectors.

 

Our Client, a leading pharmaceutical company, is seeking an experienced Senior QA / Validation Engineer for a contract role based in Cork. 


Responsibilities

  • Providing site QA oversight and approval of validation lifecycle documentation for plant equipment, IT / automation systems, facility and utility systems
  • Coordination of site periodic review program
  • QA oversight on data integrity for IT and automation systems
  • Providing QA oversight and approval for change controls, deviations and CAPAs
  • Management and implementation of validation masterplans and SOPs

Qualifications

  • Degree level qualification in Science/Engineering or equivalent
  • Minimum 8 years' experience in a Quality role within Pharmaceutical/Medical Device industry.
  • Proven ability to successfully introduce new product development in the Medical Device/Pharmaceutical Industry.
  • Proven knowledge and ability regarding product verification and process validations including software and automation experience.
  • Proven knowledge of FDA and MDD GMP requirements regarding Medical Devices and Pharmaceutical.