Company: Chemo
Region: Azuqueca de Henares , Castile-La Mancha
In a few words Position : Stability R&D Coordinator Location : Azuqueca de Henares (Guadalajara) Experience : 3-4 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. Ready to be a #Challenger? What are we looking for? We are incorporating a new INSUDER as Stability R&D Coordinator to join the R&D team at our plant in Azuqueca de Henares. The challenge! Anticipate for laboratory material needs and equipment required. Stability Database and stability chambers manteinance Provide technical support to the team. Approve Stability Protocols and general stability documentation. Investigate Out Of Specifications and Out of Trend results (OOS and OOT), significant changes and anomalous results and approve the documentation associated with them in a timely manner Lead investigations to find the root cause of OOS and OOT and propose CAPAs in collaboration with QA Write the stability reports to established retest dates and temperature restrictions when neccesary Write change controls and SOPs related stability studies Advise on the recruitment process of laboratory analysts to assess the technical knowledge of the candidates. Be aware and constantly review of regulatory guidances that apply to the stability testing What do you need? Education: Degree in Chemistry. Languages: Fluent Spanish and English Experience (years/area): 3-5 years of experience in Pharma industry in a similar position. Specific Knowledge: ICHs, pharmacopoeia EP and USP and GMP regulations. Travels: if required. Personal skills: good communication skills, customer-oriented, proactivity, Organizational skills. Our benefits! Flexible start time from Monday to Friday (full-time). Permanent contract. Attractive salary package. Life and accident insurance. Ticket restaurant On-site medical service Benefits and Savings Club. Training and language learning platform Wellness platform with unlimited free psychologist sessions Cabify transportation service for employee use Development plans, internal mobility policy. Many more! What will the Selection process be like? Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels. Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test. Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process. Do you think this offer is not for you? Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting! #InsudPharma #Challenger #Insuder #InsudTalent 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.