Senior QA Specialist Technical Support
TEAM HORIZON
Dublin
6d ago

Why you should apply :

  • This is an exciting opportunity to take on a senior position within the QA function. You will be required to be a Subject Matter Expert in your assigned area of responsibility.
  • What you will be doing :

  • Provide 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 are robust and in keeping with regulatory and company expectations.
  • Quality review and approval of Validation documentation and SOPs to support site validation activities : Review of DS & QRAES documentsReview of validation Plans, Protocols, IQ, OQ, PQ and associated validation documentsReview 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 company and 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 and Deviation Review Boards 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 company safety standards and SOPs
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
  • What you need to apply :

  • University degree. Science or Engineering related discipline preferred.
  • Relevant experience (5yrs +) working in the Medical Device, pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Understanding of principles of Validation and New Product Introduction
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Ability to operate across functional boundaries, both internal and external.
  • Ability to work independently and remotely with minimum direct supervision.
  • Critical thinking skills
  • Apply
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