Contract Opportunity - Lead Certification Auditor - Pharma, Cosmetics and Personal Care (PCPC)
We are SGS – the world's leading testing, inspection and certification company. Recognized as the global benchmark for sustainability, quality and integrity, our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
About the role
Join our team as a Contract Lead Certification Auditor and play a critical role in ensuring compliance with industry standards and regulatory requirements. The Contract Lead Certification Auditor - Pharma, Cosmetics, and Personal Care (PCPC)/Medical Devices performs third-party audits per SGS Certification procedures and the applicable standards. They are responsible for making relevant decisions regarding the audit process and informing SGS Business Assurance on issues resolution outside the audit process.
The PCPC/Medical Devices Auditor collects and analyzes sufficient information to provide a recommendation for certification and has authority for the control and performance of auditing activities, including planning and control of other members of audit teams. This is a contract role requiring authorization to travel to and provide auditing services in the United States, Canada, and Mexico.
Responsibilities
- Qualify as a Lead Auditor in more than one standard (e.g., ISO 22716, EU GMP, WHO GMP/GDP, EFfCI and EXCiPACT, ISO 15378, ISO 9001) and conduct integrated audits where required as per SGS global procedures, local procedures, guidance, and instruction of Technical Manager.
- Perform certification audits in any capacity in conformance with SGS Global/Local procedures, sector-specific schemes/standards, ensuring duties are performed efficiently and commercially expediently.
- Provide determinations on whether registration should be recommended or allowed to continue based on audit evidence.
- Assimilate, understand, and operate the SGS Certification System in all auditing activities.
- Collaborate with teams of auditors during auditing activities.
- Strive to provide customers with sufficient audit experience to cover SGS’s Certification's accredited activities.
- Actively participate in witness audits by SGS or accreditation bodies.
- Maintain all audit-related credentials.
- Adhere to internal standards, policies, and procedures.
Requirements
- Bachelor’s degree in science or bio-science (consideration will be given to other science fields, e.g., chemical science, depending on additional training related to pharmaceutical, cosmetics, and personal care subjects).
- Minimum 5 years' work experience in a proven management function in the PCP industry, with at least 2 years in a Quality Assurance function or quality & safety management system coordination (required).
- Minimum 5 years of auditing experience and qualification as an ISO Lead Auditor, especially in Pharmaceutical or OTC products (required).
- Minimum 4 years of medical device experience (preferred).
- Experience with ISO 14001, ISO 45001, and/or ISO 50001 based management systems (preferred).
- Experience in delivering training (preferred).
Skills
- Advanced level English (required).
- Spanish language skills (preferred).
Schedule
- Travels up to 80% of the time – automobile/airplane, including some international travel with flight times of 8+ hours depending on the destination.
- Weekend travel may be necessary to meet utilization requirements.