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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Specialist


Reference:RK23094 Location: Tipperary
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Specialist

Quality Specialist
RK23094
Contract – 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


The Quality Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities


Duties:

  • Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  • Perform and review complaints and deviation investigations, change controls and CAPA’s.
  • Creates and maintains assigned SOPs.
  • Compiles data for reports and presentations, provides data interpretation draws conclusions.
  • Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
  • Support product recalls and stock recoveries as appropriate.
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
  • Identify compliance gaps and make recommendations for continuous improvement
  • Assists in the induction process for new starters and training of other staff.
  • Generally, follows standard procedures and consults with manager/supervisor on exceptions.
  • Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
  • Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
  • Represents department on cross functional teams.
  • Additional activities as assigned by the manager/supervisor

Educational and Experience
  • Degree qualification (Science/Quality/Engineering).
  • 4+ years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
  • Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.