VALIDATION TECHNICIAN - INJECTABLES UNIVERSAL FARMA

About us:Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).COMMITMENT TO EQUAL OPPORTUNITIESInsud Pharma is aware that business management has to be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on 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.Global Responsibility Perform the validation of the new manufacturing processes arriving the companyregarding injectable products (manufacturing processes, aseptic process, cleaning, secondary packaging, etc.). Specific responsabilitiesDevelopment of validation protocols and reports and perform the supervision of the validation requirements in order to prepare all the documents associated to the validation exercises for the new manufacturing process.Development of validation protocols and reports and perform the supervision of the validation requirements in order to prepare all the documents associated to the cleaning validation exercises, according to the Cleaning Validation Master plan of the company.Assuring the execution of the media fill exercises in the filling lines according to the Media Fill Master Plan. Develop the protocols for the execution of them as well as collect the data to develop the corresponding reports.Review validation protocols and reports performed by internal or external personnel ensuring proper execution and performance of activities.Participate as an expert in external audits and inspections.Maintain the archive of validation documentation.Qualification of visual inspection sets.Management of quality systems (deviations, change control, CAPA plans…) associated with specific qualification and validation tasks.Train the new incorporations in the specific activities and functions of the position in which you are an expert. RequirementsEducation: University degree in Pharmacy, Chemistry, Chemical Engineering, or similar.Languages: Spanish and English.Experience (years/area): 3-4 years in the Validations, Technical Services, Quality Assurance or Production Department of a pharmaceutical plant, preferably in a manufacturing plant for injectables.Specific knowledge: GMP (EU and FDA