R&D Qa Technician
hace 2 días
Burgos
ppINSUD 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. /p pThe 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 RD 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. /p pThe challenge: /p h3Specific Responsibilities /h3 ul liCollaborate with the Head of QA-RD in the implementation and maintenance of a Corporate Quality System in RD in compliance with GMP. /li liWrite and review corporate procedures which allow to standardize the RD Department activities and to assure their adaptation to the correspondent Good Manufacturing Practices. /li liReview and approve documents generated by RD (e.g. Analytical validations, master batch records, procedures, and analytical methods). /li liReview and approve executed batch records and analytical results of RD before their release. /li liIssue and review RD analytical specifications. /li liPerform internal and external audits. /li liCollaborate with the Head of QA-RD in the preparation and attendance of clients audits and Health Authorities inspections. /li liIssue and organize the documentation sent from QA to RA for new submission of MA and to answer DL. /li liCollaborate in GMP training of RD employees. /li liTrain the new incorporations in the specific activities and functions of the position in which you are an expert. /li /ul h3Requirements and personal skills /h3 ul liEducation: Degree in Health Sciences (e.g. Chemistry, Pharmacy, Biology or Medicine) with supplementary knowledge of Quality and GMP. /li liLanguages: Fluent Spanish and English, knowledge of other languages will be an asset. /li liExperience (years/area): +2 years in Quality Assurance and desirable experience in RD. /li liSpecific Knowledge: Quality procedures and GMP. /li liTravels: Not required, may occur occasionally. /li /ul h3COMMITMENT TO EQUAL OPPORTUNITIES /h3 pThe 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. /p pRD QA Technician Castilla and Leon, Spain /p /p #J-18808-Ljbffr