Our client is assessing their facilities for compliance to US Pharmaceutical Manufacture Regulations and EU Requirements. This project will commence with an assessment of their facilities in Guadalajara, Jalisco, Mexico, and will continue to other facilities as defined by the client.

Our client requires a full assessment of their production processes from raw material intake to end product fill and ship. The assessor must be bilinugually fluent in English and Spanish.

This project will require remote preparation activities and on-site assessment. It is anticipated to commence in April 2024.

Off-site document and record review

Expected documents to review include, but are not limited to: 

·         Guiding Quality Documents 

·         Training records 

·         List of all SOPs 

·         Specific Procedures: Procedures for all processes performed in the facility will be reviewed. 

·         Validation protocols, records, and final reports 

·         Batch records 

·         Test methods and results, including final release testing 

·         Specific records for sales to EU member states as required, and as guided by The client’s targeted sales plan 

On-site activities: it is expected that onsite activities will require up to three days on site. Activities are expected to include, but may not be limited to: 

·         Review of additional records as identified in off-site review 

·         Interviews with area leads and other personnel as required 

·         Walk-down of manufacturing lines at the Guadalajara site. This walk-down will include, but may not be limited to: 

·         Inspection of all production areas and procedures, including personnel interviews 

·         Inspection of Warehousing and segregation, including personnel interviews. It is expected that this area includes an inspection of incoming Quality processes and procedures 

·         Inspection of Chemistry Laboratory for necessary procedures, equipment, and materials, including personnel interviews  

·         Inspection of cleaning procedures and environmental controls.

Remote Activity: Final report: Writing and review (Off-site) to include: 

·         Summary of activities 

·         List of documents reviewed 

·         List of The client personnel interviewed 

·         Findings, prioritized as Major, Minor, and Observations. This report will provide proposed activities to clear each finding, and will be the basis for The client’s review for full compliance to US 21CFR210, US 21CFR211, and the define EU Regulations. 

Required Education and Experience: 

·         Degree in Engineering, Biology, Chemistry or related industrial science

·         A minimum of 10 years working in pharmaceuticals or a related field

·         Ability to work independently, demonstrating judgement, technical acumen, courtesy, and professionalism.

·         The candidate should have the ability to travel to the client site, walk moderate distances, stoop to inspect equipment and climb using stairs to complete a waldown of a chemical manufacturing area.