Summary:
Role Responsibilities:
- 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 self-starter with ability to work both independently and within a cross-functional team




- Other duties within the compliance assessment as areas for improvement are identified.
Qualifications:
- 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 210/211.
- 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

📌 R&d Assessor, Bilingual English/spanish (Guadalajara)
🏢 Compliance Team
📍 Guadalajara