QA Validation

2022-05-13 12:08:142049-10-11Team Horizon
Job TypeContractor
LocationWestmeath
AreaRoscommonWestmeathRoscommonIrelandWestmeath
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2467
Job Views204
Description
QA Validation Specialist – Team Horizon
We are seeking applications for an experienced QA Validation Specialist (12-month contract) for our client, who are a leading biopharmaceutical company. In this role you will perform review and approval activities in the client’s cGMP commercial and clinical requirements for their manufacturing facility.  
 
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
  • Maintenance of a strong Quality culture throughout the project through operational activities.
  • Provide QA support for risk-based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
  • Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies, and regulations.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • Ensure and participate in the Quality Assurance support to internal manufacturing and technical groups. Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report, and protocols).
  • Authoring, review, and approval of QA validation -related procedures.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).  
  • Support the vendor quality management programme.
  • Complete Audits as required.
  • Develop and report quality metrics for validation/verification.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
What you need to apply:
  • Degree in Science or similar discipline
  • Post-graduate studies as appropriate to augment primary degree is desired
  • 3-5 years’ experience in Quality/validation environment.
  • Drug Product and Drug Substance experience
  • Excellent attention to detail
  • Good communication, teamwork and problem-solving skills
 
 
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Darcy Ainscough-Denton
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