-
Job Description
Senior QA Specialist
PE Global is recruiting for a Senior QA Specialist on behalf of a leading pharmaceutical company based in Dublin North.
This is an initial 12-month contract role.
Key Responsibilities:
- Support key stakeholders during the preparation and management of audits/inspections.
- Support the development of the schedule/plan and its communication.
- Lead the creation of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit.
- Review and approval of audit reports and issuance.
- Input data/feedback from report/response entry into the Quality Management system and tools.
- Lead the review of audit actions from receipt to closure.
- Support quality system metrics review and reporting.
- Support the team during audits and inspections, by taking on activities to support inspection/audit readiness.
- Lead audit consultancy communications in the management of the audit program.
Requirements:
- Minimum of 5 years experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge.
- Clear understanding of the audit lifecycle, from planning, conduct to closure.
- Demonstrable communication and project management skills; experience working in cross-functional teams.
- Strong Business Partner with a focus on collaboration and delivering results.
- Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.).
Skills:
- Quality Assurance
- Audits
- GMP
- Quality Systems