Senior Quality Specialist (Audit & Compliance Support)
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2346 |
| Job Views | 101 |
- Description
- We are currently recruiting a Senior Quality Specialist who will be responsible for working with a quality mindset within our Clients Central Quality and Compliance team. You will support the audit and inspection function, and manage the end-to-end process for audits and inspections, including preparation, conduct and supporting the response commitment process, ensuring best practices are implemented and employees fully educated in the audit/inspection management system and processes.
Why you should apply:
This is an exciting opportunity to an integration and increase in supplier audits and manage the end-to-end process for audits and inspections,
What you will bedoing:
Responsible for delivery of quality assurance activities at Companies Central Quality and Compliance function to support the audit and health authority inspection function.
Support the GMP/GDP Audit / Health Authority inspection program, including but not limited to:
Support key stakeholders during the preparation and management of audits/inspections.
Support the schedule / plan development and its communication.
Support report/response review and entry into the Quality Management system.
Support commitment tracking to closure.
Support in quality system metrics review and reporting.
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/inspection 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.
What you need to apply:
A 3rd level degree in a science, quality or engineering discipline
3-5 years’ experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge.
Direct experience of GMP management within a pharma/biopharma/medical device company is essential.
Exposure to audits (internal, supplier or corporate) or inspectorates (e.g. HPRA, FDA, NSAI) is an advantage.
Demonstrable 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.).
