Reports to: UL Registrar Technical Services Manager
Primary Task (Project Based):
As assigned will perform and manage GMP (CFR)/Quality System/Supplier Management audits at facilities designated by various clients. (21 CFR 210/211, 21 CFR 111, 21 CFR 820)
Performs on-site reviews of the Client’s Quality System documents and/or records to assist in determining the level of compliance with GMP (CFR)/Quality System/Supplier Management requirements.
Audit on-floor Quality System processes to determine compliance to CFR requirements and correlation to QS written procedures.
Represents the audit team to the Client and/or supply site management.
Executes audits effectively and efficiently using tools provided.
Assures that audit reports and results are produced to meet quality and timeliness standards.
Follows appropriate company administrative, personnel, confidentiality, business ethics, conflict of interest and safety policies and procedures.
Keeps the Field Operations Supervisor informed verbally and in writing of activities and problems within assigned areas of responsibility.
Conduct reviews of Corrective and Preventive forms used by audited sites, in regards to root cause and proposed actions.
Coordinates, leads, and directs audit team activities and reporting (as applicable).
When assigned, perform Technical Reviews for GMP audits executed independently by other auditors per company policies and within defined timeframes.
Keeps abreast of current CFR (21 CFR 210/211, 21 CFR 111, 21 CFR 820) and program requirements.
Complies with applicable internal auditing requirements and other appropriate directives.
Participates on various professional technical committees where applicable.
Objectives of the Role:
Interested, Qualified Experts should demonstrate, through suitable means, their knowledge of, and capability of using, the necessary management skills required in the execution of an audit, which are recommended in ISO 19011 and/or the ASQ Fundamentals of Auditing, as follows:
effective oral communication skills in asking questions, meeting discussions and in formal settings;
effective writing skills to clearly and concisely express observations, findings and conclusions.
Interested, Qualified Experts should have the ability to:
make decisions in an intelligent, decisive, and authoritative manner;
assess situations related to potential problems or conflicts and take appropriate actions;
manage an audit, keep the focus of activities within the scope of the audit, and be observant to determine when changes are required;
have and maintain a professional image and credentials (as applicable);
conduct and control meetings of the on-site audit team, and between the audit team and auditee (as applicable);
manage conflict between others and within the audit team (as applicable);
coordinate and manage a team of auditors for on-site audits (as applicable)
Telecommuting is allowed.
About UL-Registrar, LLC
UL Registrar is seeking qualified Independent Contractors to perform GMP audits. Interested, Qualified Experts should demonstrate, through suitable means, their knowledge of, and capability of using, the necessary management skills required in the execution of an audit, which are recommended in ISO 19011 and/or the ASQ Fundamentals of Auditing, as follows:
• effective oral communication skills in asking questions, meeting discussions and in formal settings;
• effective writing skills to clearly and concisely express observations, findings and conclusions.
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