Quality Assurance Director

3 days ago


County Dublin, Ireland Life Science Consultants (Lsc) Full time
Job Description

LSC have a fantastic contract opportunity for a Quality Assurance Specialist to join a Biopharmaceutical company in South Dublin. This is an ideal position for someone with 7+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry who is looking for their next challenge.

About the Project - Key Responsibilities:
  • Provide overall quality direction and oversight for key functional areas (i.e., Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies, and procedures are robust and in keeping with regulatory expectations.
  • Quality review and approval of Validation documentation and SOPs to support site validation activities:
    • Review of DS & QRAES documents
    • Review of validation Plans, Protocols, IQ, OQ, PQ, and associated validation documents
    • Review of executed validation documents and reports
  • 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.

About You - Are Your Skills a Match?
  • University degree
  • Science or engineering-related discipline preferred
The ideal candidate will have relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e., Packaging, Validation, Quality Control, Engineering, Information Systems). They should also have understanding of principles of Validation and New Product Introduction experience in change control, non-conformance, corrective and preventative actions, and validation practices. Strong organisational, communication, coordination, and meeting facilitation skills are essential. The successful candidate will be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication and collaboration.

Benefits Include:
  • Opportunity to work on challenging projects
  • Develop your career in a dynamic industry
  • Collaborate with experienced professionals


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