Research and Development Auditor
hace 3 semanas
Job Summary:
As a member of the Compliance Team, we seek an experienced R&D Assessor, Bilingual English/Spanish to join our team.
About the Role:
- Review product process documentation and laboratory notebooks/records to ensure processes and 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.
Requirements:
- 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 manufacturing.
- Excellent analytical and investigation skills.
- Fluent in technical English and Spanish both speaking & writing.
- Good interpersonal skills.
- Excellent organizational skills.
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