Auditor/Lead Auditor Pharmaceuticals or Medical Devices
An Auditor performs internal and/or external audits alone or in a team. An Auditor is also a team member in a team lead by a Lead Auditor.
To be certified as an Auditor you shall, in addition to have passed a theoretical exam, have performed at least 6 (six) quality system audits where at least 3 (three) shall be external (e.g. supplier audits) OR you shall have performed at least 10 (ten) internal audits. These audits shall in total have covered all applicable requirements in relevant standards/regulations. These audits shall have covered document review, preparation, on site audits and audit reporting.
As auditor, you are not expected to have experience from leading or coordinating an audit team.
The exam choice (pharmaceutical or medical device) and your experience will guide the issuance of a certification for either pharmaceuticals or medical devices.
In addition to the required experience and competence for Auditor, a Lead Auditor shall have additional knowledge and competence to be able to lead and coordinate a team of auditors.
To be certified as Lead Auditor you shall, in addition to have passed the theoretical exam, have the same experience as required to be Auditor (as above), also have worked in a team coordinated by another Lead Auditor and have performed at least 4 (four) quality system audits (internal or external) as Lead Auditor and have coordinated a team of at least one additional person.