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Manufacturing deviations specialist

Reference:/RH/A008952 Location: Dublin
Dublin South
Qualification:DiplomaExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Manufacturingdeviations specialistrequired for a contract role with a Dublin based Biopharmaceutical facility.

The manufacturing specialist will be primarily responsible for resolving fill/finish deviations. Specific responsibilities include but are not limited to:

  • Working closely with Quality, Engineering, Process Development, Validation, Manufacturing, Inspection and Packaging to resolve deviations in a timely manner.
  • Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA).
  • Assuring appropriate escalation to various levels of management when timeline requirements for deviation processing are exceeded.
  • Assisting as needed in audit by external agencies in answering questions related to deviations
  • Performing other duties as required by Manufacturing Management.

Education and Experience:

  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality.
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
  • Project Management experience
  • Experience interacting with representatives of regulatory agencies.
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
  • Detailed technical understanding of fill/finish operations
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong technical writing and presentation skills
  • Ability to be flexible and manage change
  • Ability to communicate and collaborate with technical and management staff

For more information contactRuth Hollandon087 7822