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Qualified Person - Biologics / Steriles Wanted In Dublin, Ireland

Published 4 days ago
Expires 2018-06-16
ID #56099
Free
Qualified Person - Biologics / Steriles Wanted In Dublin, Ireland
Ireland, Dublin, Dublin,
Published 4 days ago

Job details:

Job type: Full time
Contract type: Permanent
Occupation: Qualified person - biologics / steriles


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Description



This Qualified Person will act as a key member of the Quality Assurance team associated with the production of our client’s Biologics product.


 


JOB PURPOSE:

This Qualified Person will act as a key member of the Quality Assurance team associated with the production of our client’s Biologics product. Based at this top Pharmaceutical company's manufacturing campus in Dublin this QP will be reporting directly to the Head of Quality for this product.



RESPONSIBILITIES:
The responsibilities of the Qualified Person will include the following:

  • Management of batch disposition and material status control activities associated with the drug product, acting as a site Qualified Person.
  • Communication and liaison with other departments on Quality issues, providing guidance and support to others.
  • Assisting in investigations on deviation management, root cause analysis and CAPAs.
  • Co-ordinate Change Control process associated with production.
  • QA oversight.
  • Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
  • Management of review of BMRs.
  • Implement of KPIs within the Quality Assurance Participation in the site Internal Audit programme.
  • Prep and host for external Audits from regulatory bodies including prep of documentation.
  • Promote quality culture. 
  • Acting as a designee to the Head of Quality as required.



REQUIREMENTS:

  • Meet the educational standards of a Qualified Person as per EU Directive 2001/83/EC.
  • 3rd Level science degree.
  • Sterile manufacturing experience essential. 
  • Biologics manufacturing experience.
  • Minimum 5 years experience in a quality role.
  • Excellent knowledge of GMP as described in current FDA & EMEA regulations for Biologics pharmaceutical manufacture.
  • Must be a self-starter with strong initiative.
  • Fantastic project management skills.



To discuss this opportunity in greater detail please contact Dominick O’Driscoll from Clarity Recruitment on +353 1 5673123 and by submitting a CV for an immediate confidential review.



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