Global Responsibility
Collaborate with the Head of QA-R&D of Chemo in order to assure the activities of R&D Department are performed in compliance with the internal SOPs, the 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 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 with the Head of QA-R&D 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.
* Train the new incorporations 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 Spanish and English, knowledge of other languages will be an asset.
* Experience (years/area): +2 years in Quality Assurance and desirable experience in R&D.
* Contract: Temporal (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 OPPORTUNITIES
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.