Descripción de la oferta
ph3About the Company /h3pInsud 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, an industrial area of the Insud Pharma group, is a world leader in RD 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). /ph3Role Overview /h3pQA Technician for our plant, LICONSA. Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance with internal procedures, GMP rules, authorities and customer requirements. EU US GMP compliance. /ph3Responsibilities /h3ulliAssure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. /liliActively participate in CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance with internal procedures, GMP rules, authorities and customer requirements. EU US GMP compliance. /liliIntegral responsibility – raw material suppliers homologation and system maintenance, risk assessment performance. /liliAudit annual plan preparation and support regarding audit performance. /liliThe role is a contact person of the company regarding quality queries to be managed with raw material suppliers or external services. /liliQuality complaints from customers: register, investigation and response. Recurrence and tendency identification. /liliPQR preparation according to timelines included in the annual plan, internal procedures and TA in force. /liliCAPA and CC system: register, evaluation and follow‑up. Performance of the specific task assigned to. /liliTraining: GMP basic training to new staff. Register and follow‑up. /liliSOPs: prepare or update specific SOPs related to the activities in charge of. /liliCollaborate in external audits from customers and authorities and conduct shelf‑inspections according to the annual plan. /liliSupport customers and authorities request for quality and technical issues. /li /ulh3Qualifications /h3ulliEducation: Degree in Pharmacy or Chemistry or Sciences. /liliLanguages: Intermediate or high level of English required and bilingual in Spanish. /liliExperience: A minimum of 3 years’ experience in a similar position. /liliKnowledge of EU US GMPs, quality systems (CAPAs, PQRs, audits support, supplier management, change controls, etc.) in pharmaceutical companies. /liliSAP and Trackwise knowledge is valuable. /li /ulh3EEO Statement /h3pEl grupo InsudPharma es consciente que la gestión empresarial tiene que estar en consonancia con las necesidades y demandas de la sociedad, y por ello asume el compromiso de igualdad de oportunidades y trato entre hombres y mujeres, tal y como se recoge en la normativa vigente en la materia -Ley Organica 3/2007, y no discriminamos a ninguna persona por motivos de etnia, religión, edad, sexo, nacionalidad, estado civil, orientación afectiva o sexual, identidad o expresión de género, discapacidad, o cualquier otra circunstancia personal o social. /p /p #J-18808-Ljbffr
