Senior QA Specialist

The role:

PE Global is currently 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.

Description:

• The Senior Quality Audit Specialist will be responsible for supporting the audit and inspection function. They are to manage the end-to-end process for audits and inspections, including preparation, conduct and supporting the response commitment process to closure.
• Support key stakeholders during the preparation and management of audits/inspections.
• Support the development of the schedule / plan and its communication.
• Ensures the timely creation and performs the review of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit.
• Ensures the timely issuance and performs review and approval of audit reports.
• Maintaining up to date data in the Quality Management system and tools.
• Ensures timely execution of confidentiality/non-disclosure agreements.
• Lead the review and approval of audit actions e.g. CAPAs 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 related activities.
• Ability to work independently and within a team as an individual contributor.
• Partner with key stakeholders in the collection of key feedback to enable the audit function to operate effectively.
• Acts as a quality point of contact for audit/inspection queries from stakeholders.
• Participate and lead continuous compliance improvement projects within the team.
• Deliver Quality Assurance review and approval of SOPs and procedural documentation.
• Act as SME / Quality contact on key Quality system records, including audits, inspections, deviations, change controls.
• Support audit conduct, when required.

Education and Experience:

• Primary Degree in Science/Engineering/Technical discipline
• 5+ years’ experience in Quality environment. Strong audit experience
• Excellent attention to detail
• Good communication, team work and problem-solving skills
• Good knowledge of relevant computer packages e.g. Trackwise, SAP and Veeva

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***