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Senior QA Manager

Job description

Senior QA Manager

Job Responsibilities

  • Set objectives for local QA manager and QA representatives
  • Ensure that local Quality Assurance teams provide oversight of calibration, validation and maintenance programs
  • Document and data management.
  • Ensure the implementation and management of Quality Systems
  • Ensure that units are compliant with the manufacturing license, customer requirements and company requirements.
  • Oversee the site audit readiness program and manage the audit process for the facilities
  • Work closely with manufacturing staff to ensure units meet customer expectations on delivery time and product quality
  • Ensure that appropriate sterility assurance level is applied and reached by processes
  • Ensure that each site implement and update yearly, a continuous training program focused on microbiology and aseptic techniques.
  • Ensure that all complaints reported by customers are appropriately documented and investigated as required.

Job Qualifications

 

  • M.Sc. qualified in life sciences
  • Strong relevant experience in Quality Assurance for the Pharma/Healthcare Industry, especially in regards to sterile aseptic products.
  • Experience with audit preparation, hosting and follow-up.
  • Front-end exposure to HPRA and MHRA inspections
  • Team/People management a must

If you think you are suitable for this Senior QA Manager job please contact Clara Henry on 01 4744676 or email chenry@sigmar.ie