Lead Auditor - Pharma

• The Lead Auditor performs 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.
• The Lead Auditor (GMP/Quality Systems) assesses and reports 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.
• The Lead Auditor maintains a high level of technical knowledge and plays an active mentoring role with trainees, auditors and lead auditors in the field.
• The Lead Auditor will participate and lead higher level audits; and as such this will involve complex methodologies, advanced analysis, and comprehensive / intricate reporting.
• The Lead Auditor writes reports in English in an objective, accurate, detailed and timely manner.
• The Lead Auditor maintains competency in Specific Regulatory Standard(s) including:

• OTC Drug/Pharmaceuticals: 21CFR210 & 211
• Nutritional Supplements: 21CFR111
• Medical/Homecare Devices: 21CFR820
• Cosmetics: ISO22716, FDA Cosmetic Guidance
• Food GMP/Safety/Defense: 21CFR117, 506, 112, and 121
• GFSI Standards (SQF, BRC, FSSC22000)
• ANSI 455 Standards (OTC Drugs, Dietary Supplements, Cosmetic)
• Natural Health Products Regulations (SOR/2003-196)
• Health Canada OTC Drug FDR Division 2, Part C

• University Degree (Equivalent to Bachelor's degree) required. Prefer Graduate Science Degree in Food or Pharma Sciences, Engineering, Technology, or similar.
• Must hold one or more scope specific professional credential(s), such as:

• GFSI recognized auditor credential;
• CQA, RABQSA, IRCA, RAC, GRMA; APIC;
• Pharmaceutical GMP Professional Certification (CPGP)
• Four years related work experience in manufacturing or retail sectors in technical, supply chain, retail operations, quality assurance or food safety and/or equivalent experience in environmental health, public health or relevant experience.
• Willingness and ability to travel to other countries, states, regions, provinces and or throughout any assigned or designated country (up to 70 to 80% annually).
• Excellent written and verbal communication skills in English and if required fully proficient/literate in a 2nd language.
• Excellent oral communication skills; capable of addressing high executive audiences and conduct opening and closing conferences in front of multiple people.
• Excellent mathematical skills and analytical skills. Creative and innovative thinking to problem solve and streamline processes.
• Ability to lead a team of auditors during the execution of a project and/or specialized audits. Proficient in internet navigation, e-mail and PC software such as Microsoft Word, Excel.

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