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Deviation Specialist (Manufacturing)

  1. Cork
  1. Contract
Competitive
26870KF
  1. Life Sciences
Date Posted01 Jun 2021
Manufacturing Deviation Specialist - Ireland - Contract

This is an exciting chance to join a fast-growing project that has ambitious growth plans. It will give the ideal candidates a chance to have a genuine impact on a state-of-the-art aseptic pharmaceutical site. 


Description:
The manufacturing specialist will be primarily responsible for resolving deviations on an aseptic site.

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)
  • Writing Technical Deviation Reports, managing review and approval with key stakeholders.
  • 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.

Requirements:  
  • 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) OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
  • Detailed technical understanding of aseptic 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

Preferred Qualifications:
  • 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
If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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