Job Description
Purpose 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. Responsibilities Key QMS experience is essential, ranging from exposure to CAPAs, deviations & change controls 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 identi?cation 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. 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. 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.). 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. Skills: Audits Quality Management Systems Veeva Vault