LSC have a great contract opportunity for a Senior QA Audit Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support key stakeholders during the preparation and management of audits/inspections.
- Lead the creation of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit.
- Input data/feedback from report/response entry into the Quality Management system and tools.
- Lead the review of audit actions from receipt to closure.
- Lead audit consultancy communications in the management of the audit program.
- Acts as a quality point of contact for audit/inspection queries from stakeholders.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
- Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or contact Gráinne Hodnett at LSC on 021-4777329 if you have any more questions about this.
