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Contact Info
Kevin Silke
Life Science

01 507 9255
[email protected]
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Regulatory Affairs Specialist
Republic of Ireland
VP of R&D
Quality Engineer
Program Manager
Risk Manager
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Senior Quality Specialist - NPI

Reference:KG-AKBK-206522 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Would you like to join a leading and successful biotechnology company in Dublin, to further develop your career? This is an excellent opportunity to work with leading technologies in the biotech industry.

As a Senior Quality Specialist, you willProvide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures.

Key Responsibilities

  • Quality review and approval of Process Development and Validation documentation.
  • Review of DS & QRAES documents.
  • Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
  • Review of executed validation documents and reports.
  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet regulatory expectations.
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Provide Quality direction and input at Change Control Review Board and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Write, review and approve Standard Operating Procedures in accordance with company Policies.
  • Perform all activities in compliance with safety standards and SOPs.

Preferred Qualifications

  • University degree. Science or Engineering related discipline preferred.
  • Understanding of principles of Validation and New Product Introduction.
  • Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems).
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.

If you meet the Preferred Qualifications, and feel this is a good role for you, please apply today!