Regulatory QC Specialist

2 weeks ago

Cork, Cork, Ireland TN Ireland Full time

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Reg affairs / Compliance QC specialist

Description

My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business, they support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Co. Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide.

This is an opportunity for a skilled QC Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.

Reporting to: Quality Manager

Main Responsibilities

  1. Management of pharmacopoeia reviews and resulting procedural changes.
  2. QC rep for Regulatory assessments.
  3. QC support for method transfer.
  4. Support method validation activities, through writing and executing protocols.
  5. Complete review/approval of validation documentation for other team members on request.
  6. Provide leadership, coaching and mentoring for QC Specialist Team.

Compliance

  1. System documentation, including SOPs, protocols, Validation lifecycle/CSV documentation.
  2. Ownership of quality systems actions (IR's, CAPA, CC) ensuring timely closure and performance trending.
  3. Act as a technical and compliance liaison between QC Functional team and Operations / Engineering / QA.
  4. Participation in internal and external audits and active follow up on audit items.
  5. Identifying productivity and compliance opportunities and driving same to completion.

Qualifications and experience

  1. Level 8 degree in Chemistry / Microbiology, or in a Science/Engineering subject.
  2. Familiar with Regulatory and ICH expectations of good laboratory practices, equipment qualification and maintenance.
  3. Familiar with QC systems and processes, especially LIMS, MODA & Veeva.
  4. Experienced in data compilation, review and report generation.
  5. Experienced in Data Integrity requirements for QC.
  6. Project Management - leading & oversight as well as contributory role.

Skills required:

  1. Highly attentive to detail.
  2. Self-motivated, goal driven person.
  3. Experienced in technical problem solving.
  4. Good organisational skills.
  5. Strong ability to perform, challenge and positively influence in an interactive team environment.

For more information, please contact Alan on 087 365 7522 / [emailprotected].

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