Overview

Reference Number: JO-2111-480491
QC Systems Specialist
Rate: Negotiable
Job Type: Contract
Location: Waterford

Have you got experience with Computer System Validation and Data Integrity? Are you looking for an opportunity to work for a global Pharma? If so this role might be for you.
CPL are actively recruiting for a QC Systems Specialist to support a Manufacturing department by maintaining and improving the QMS.

Key Responsibilities:

  • Write, review and approve site documentation in accordance with regulatory and site requirements.
  • Conduct Site Internal Audits ensuring alignment with regulations, global documents and site documents
  • Responsible for challenging current procedures interpretation of trend data and for making necessary revisions to Quality programs to afford optimisation and further development of existing Quality standards and overall compliance.
  • Oversight and management of Quality Risk Management process and for the embedding of QRM principles within the Quality Framework
  • Responsible for trending programs associated with deviations/CAPAs/Change Controls. Ensuring ouputs are providing key indicators as to program efficacy.

Qualifications:
BSc, MSc or PhD in Science or Engineering related subject

Experience:

  • Relevant 3- 5 years working within a Quality or Manufacturing department in a Pharma or Biotech industry.
  • Previous QMS or QRM experience
  • Previous Computer Systems Validation or Data integrity experience
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