QUALITY ASSURANCE R&D TECHNICIAN

We are devoted to enhancing health and wellness. Chemo is a global leader in R&D and manufacturing for over 100 value-added active pharmaceutical ingredients and more than 50 medicines with over 200 different product presentations. We do that with the best team ever. A team that shares information openly, broadly and proactively. A team filled with tenacious, optimistic, open-minded and creative people looking for the best ideas, helping their colleagues and collaborating effectively with people of diverse backgrounds and cultures. Join us!

Be part of QA-R&D team assuring the activities of R&D Department are performed in compliance with the internal SOPs, the GMP and EMEA and FDA legislation.

• Implementation and maintenance of a Corporate Quality System in R&D in compliance with GMP.
• Write and review corporate procedures which allow to standardize the R&D Department activities and to assure their adaptation to the correspondent 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 in the preparation and attendance of clients audits and Health Authorities inspections.
• Issue and organize the documentation sent from QA to RA for new submission of MA and to answer DL.

• Collaborate in GMP training of R&D employees.

• Education: Degree in Health Sciences (e.g. Chemistry, Pharmacy, Biology or Medicine) with supplementary knowledge of Quality and GMP.
• Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
• Experience (years/area): +2 years in Quality Assurance, Analytical Development or Quality Control.
• Specific Knowledge: Quality procedures and GMP.
• Travels: Not required, may occur occasionally.
• Personal skills: Good communication skills, customer orientation, proactivity, organizational skills.