R&d Assessor, Bilingual English/spanish - Guadalajara, México - Compliance Team

Descripción

• Collaborate as a contributor in an assessment team to ensure that pharmaceutical excipients meet worldwide requirements.
• Review product process documentation and laboratory notebooks/records to ensure processesand equipment in the laboratory are properly validated, that training requirements, are met, risks are identified and managed, and overall process transfer has resulted in safe product.
• Perform a thorough evaluation of the R&D process and SOPs at the plant within specified time limitations, interviewing R&D personnel to confirm that SOPs are understood and followed.
• Collaborate with the assessment team to prepare a report for the client in English and Spanish to facilitate future improvements.
• Strong selfstarter with ability to work both independently and within a crossfunctional team
• Other duties within the compliance assessment as areas for improvement are identified.

• Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum five (5) years of experience in a pharmaceutical production and R&D environment or equivalent combination of education and experience.
• Knowledge and understanding of ExciPACT, EMA, and HealthCanada requirements for excipients as well as 21 CFR 210/21
• Strong R&D and auditing experience in pharmaceutical and/or contract manufacturingExcellent analytical and investigation skills
• Fluent in technical English and Spanish both speaking & writing
• Good interpersonal skills
• Excellent organizational skills