QA Specialist

  • Westmeath
  • Temporary 15 months
  • JO-1706-62591_1497265323

Summary

QA Specialist
contract until Oct 18

Responsibilities

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility.
  • Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • QA support for implementation of Manufacturing Execution System (MES) and development of batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).

Requirements

  • B.Sc. in Science/Engineering
  • Min 4 years QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.
  • Protein purification experience is highly desireable.

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