R&D QA Technician
hace 11 días
León
In a few words Position: R&D QA Techinician. Location: León. Experience: Between 1-3 years. Want to know more? INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health. The activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. The challenge: 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. 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. • 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 The InsudPharma group is aware that business management must align 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 regulations on the matter - Organic Law 3/2007, and 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.
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