Intertek is looking to hire independent contractors in the MidWest, West Coast and South Central regions of the U.S.
The purpose of this position is to lead and participate in GMP Audits to assure that client sites supply products that have been manufactured under GMP and in accordance with client requirements and in compliance with applicable US FDA, EU, ICH GMP Guidelines and other government and/or country specific regulations.
In addition: • Manage audit responses to closure and provide effectiveness verification. • Participate in Auditor Team meetings and other consultative meetings as requested. • Participate in the improvement of the GMP auditing program
RESPONSIBILITIES The ideal candidate will possess the following qualifications: • BA/BS Chemistry, Biology or related scientific degree • 7-15 years of related industry experience in an analytical laboratory • Related 3rd party auditing industry management systems preferred • Knowledge in the regulatory standards FDA, ICH, DEA, ISO, GXP • Knowledge in EU, TGA, Health Canada not required, but preferred • Should have experience in GMP FDA Regulations Parts 210-211, 820, 110, 111, Cosmetic Guidelines
Perform onsite GMP compliance audits • Opening and closing meetings • Assess compliance with FDA, EU regulations and guidelines, International Conference on Harmonization (ICH) guidelines and the client’s requirements and specifications. • Review the qualifications and training • Review SOPs to ensure procedures and systems used in the manufacturing process are in compliance with applicable guidelines and regulations, including SOPs for OOS, recall, deviations, complaints, CAPA, QA responsibilities, batch record release etc. • Assess compliance with internal SOPs • Inspect facilities, productions, QA laboratory, warehouse, shipping/receiving • Inspect equipment, qualification, calibration, maintenance • Review records and procedures for validation, process, equipment, computer systems • Review of batch records, DMF, organizational structure • Review of regulatory inspection reports • Assess clients requirements have been met by the site. • Final report generation • CAPA assignment, monitoring and closure • Manage travel arrangements • Ensure all travel arrangements are in compliance with applicable travel policies. • Maintains current knowledge with industry expectations
EDUCATION Requires a BS or equivalent in science with a minimum of 5-8 years related experience or equivalent training and experience in the Pharmaceutical, Biotechnology or Medical Device industry. • Minimum of 5 years, actively participating in a GMP lead auditor role. • Current knowledge of US Code of Federal Regulations, EU and ICH Guidelines governing GMP and recent initiatives. • Experience in international compliance and auditing. • Must be detail oriented, with excellent oral and written communication skills. Also, must be able to partner with a diverse group of staff/international consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality. • Ability to work independently and as part of a team in a very busy and fast moving working environment and be diplomatic, self-assured, and flexible in professional and personal approaches. • Auditor certification is a plus.