FAQs
What is the job title for this position?
The job title is Quality Assurance Lead Auditor.
What type of company is Inizio Engage recruiting for?
Inizio Engage is recruiting for a rapidly growing privately owned business involved in the development, manufacture, and testing of pharmaceutical and biotechnology products and medical devices.
Is this a newly created role?
Yes, this is a newly created role that will be the start of the client developing its own corporate audit team.
What are the key responsibilities of the Quality Assurance Lead Auditor?
Key responsibilities include managing the audit schedule, training internal auditors, generating and reviewing SOPs, and managing QPulse related to audits.
What experience is required for this position?
A proven track record of QA internal/external auditing in the pharmaceutical or biotechnology industry, lead auditor experience in GMP areas, and inspection experience with agencies like FDA and MHRA are required.
Will the Quality Assurance Lead Auditor have the opportunity to create their own team?
Yes, this role offers the opportunity to create and lead a new audit team within the organization.
How long should applicants expect to wait for a response after applying?
Applicants should expect to hear from a member of the resourcing department within 7 days; if not, it indicates that the application has been unsuccessful at this stage.
What system will the Quality Assurance Lead Auditor manage in relation to audits?
The Quality Assurance Lead Auditor will manage QPulse relating to audits, including audit scheduling and management of audit non-conformances.