Global Responsibility: Collaborate with the Head of QA R&D of Chemo to ensure that the activities of the R&D Department are performed in compliance with internal SOPs, GMP, and EMEA and FDA legislation. Specific Responsibilities: Collaborate with the Head of QA R&D in the implementation and maintenance of a Corporate Quality System in R&D in compliance with GMP. Write and review corporate procedures to standardize R&D Department activities and ensure adaptation to Good Manufacturing Practices. Review and approve documents generated by R&D (i.e., Analytical validations, master batch records, procedures, and analytical methods). Review and approve executed batch records and analytical results of R&D before their release. Issue and review R&D analytical specifications. Perform internal and external audits. Collaborate with the Head of QA R&D in the preparation and attendance of client audits and Health Authorities inspections. Issue and organize documentation sent from QA to RA for new submission of MA and to answer DL. Collaborate in GMP training of R&D employees. Train new hires in the specific activities and functions of the position in which you are an expert. Competencies/Career Level: Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self development, sense of urgency, initiative. Requirements and Personal Skills: Education: Degree in Health Sciences (e.g., Chemistry, Pharmacy, Biology, or Medicine) with supplementary knowledge of Quality and GMP. Languages: Fluent in Spanish and English; knowledge of other languages is an asset. Experience: 2+ years in Quality Assurance with desirable experience in R&D. Contract: Temporary (6 8 months). Specific Knowledge: Quality procedures and GMP. Travels: Not required, may occur occasionally. Personal Skills: Good communication skills, customer orientation, proactivity, organizational skills. COMMITMENT TO EQUAL O ORTUNITIES: We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. #J 18808 Ljbffr