Senior QA Validation Specialist

Posted on: 18/12/2017
Ref: VAC-16156
 
  • Country: Ireland
  • Location: Dublin
  • Industry: Commissioning/Validation
  • Discipline: Validation Engineer
  • Employment Type: Contract
  • Duration: 24 weeks+

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Job Description

A QA Validation Specialist is required for a 12 month contract, working onsite at LSC’s major biopharma client based in west Dublin. This is a key role providing site wide QA activities to support the start up activities of the bulk drug substance manufacturer.

As QA Validation Specialist you will:
o Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
o 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.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
o QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
o Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
o Authoring, review and approval of QA-related procedures.
o Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.

Requirements:
-BSc. in science/engineering with a minimum of 8 years QA experience in a pharmaceutical -manufacture/biopharmaceutical environment.
-Strong process knowledge to include upstream and/or downstream processing.
-Bulk Drug Substance experience is essential.

Call or email Kathy on 021 4777329 / kgillen@lsc.ie for futher info on this and other QA and Validation roles.

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