R&D Assessor, Bilingual English/Spanish

Summary:

Compliancde Team, LLC has clients in Mexico that market pharmaceutical excipients worldwide. This client is undertaking remediation to ensure its site operations conform to worldwide regulations related to pharmaceutical excipients. We seek a Spanish-speaking industry professional who can interact with R&D personnel to assess the R&D process to assure that proper product development is undertaken, records are comoplete, and regulations supporting R&D and technology transfer are met. This individual will have a working knowledge of USP and EMA, Health Canada, ExciPact, and United States (21 CFR 210/211) requirements, as they apply to the R&D process.

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
• Chemiscal plant is very spread out and candidate should be able to walk extensively, to cover the area.

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