Lead Auditor Manufacturing

Lead Auditor - GMP Quality Audits will perform high level assessments of quality systems in a variety of manufacturing sites, farms, processing plants and/or other work related sites throughout a region or country.

Assess and report in accordance with UL, industry scheme, and client audit protocols on facilities working and/or operational conditions as it relates to established industry standard(s) for GMP, Quality Systems, Food Safety initiatives and/or client programs.

Maintain a high level of technical knowledge and play an active mentoring role with trainees, auditors and lead auditors in the field.

Participate and lead higher level audits; and as such this will involve complex methodologies, advanced analysis, and comprehensive / intricate reporting. Reports will be written in English in an objective, accurate, detailed and timely manner.

Specific Regulatory Standard(s) Competencyare a focus including:

OTC Drug/Pharmaceuticals: 21CFR211/210

Nutritional Supplements: 21CFR111

Medical/Homecare Devices: 21CFR820

Cosmetics: ISO22716

Complete audit agendas within 14 calendar days of the audit

Complete reports within 4 calendar days of the audit

Submit audit expenses in a timely manner

Complete at least 10 days of audits per month minimum capacity.

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