Job 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.
Day to day activities include, but not limited to:
o Support key stakeholders during the preparation and management of audits/inspections.
o Support the development of the schedule / plan and its communication.
o 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.
o Ensures the timely issuance and performs review and approval of audit reports.
o Maintaining up to date data in the Quality Management system and tools.
o Ensures timely execution of confidentiality/non-disclosure agreements.
o Lead the review and approval of audit actions e.g. CAPAs from receipt to closure.
o Support quality system metrics review and reporting.
o Support the team during audits and inspections, by taking on activities to support inspection/audit readiness.
o Lead audit consultancy related activites.
o Ability to work independently and within a team as an individual contributor.
o Partner with key stakeholders in the collection of key feedback to enable the audit function to operate effectively.
o Acts as a quality point of contact for audit/inspection queries from stakeholders.
o Participate and lead continuous compliance improvement projects within the team.
o Deliver Quality Assurance review and approval of SOPs and procedural documentation.
o Act as SME / Quality contact on key Quality system records, including audits, inspections, deviations, change controls.
o Support audit conduct, when required.