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Analytical Validation & Transfer Technician

hace 7 días

Esplugues de Llobregat

BELIEVE IN LIFE. Join a company that takes you further! Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide. People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values. Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!) We are looking for a Analytical Validation & Transfer Technician to join our I+D Team. What you'll be rocking: Writing Protocols & Reports of analytical validation of new analytical methods for active pharmaceutical ingredients and finished dosage forms. Writing Protocols & Reports of transfers analytical methods between different Sites for active pharmaceutical ingredient and finished dosage forms. Management and review of the documentation provided by CRO’s and CMO’s in reference to the analytical validations & transfers activities. Management of all the material (such standards, samples of finished product, HPLC Columns,etc) needed to complete related activities. Act as an interlocutor between the transferring laboratory and receiving laboratory. Managing day.to.day operational aspects of projects and the laboratory including the analyst management. Review the possible changes that should take place in the analytical methods developed by the company and analytical support for the new development. Technically guide the staff of whom in charge and provide answers and support to allow them to generate valuable results. Response to deficiency letters, regulatory agencies and clients regarding AVT activities. Drafting of technical reports and SOPs related to the area as well as the proposal of inter and intra-departmental improvement flows. Collaboration in the tasks of elaboration, writing and presentation of the analytical dossier of the different products of the company. What you bring to the table: Minimum 2 year experience in Analytical Validation & Transfer activities in GLP/GMP environment, preferably in the Pharmaceutical Industry , showing proven experience in the development and validation of most of the following analytical methods: HPLC, UPLC, LC-MS, GC, UV-Vis, DSC, PSD, potentiometric titration, IR, KF Titration and Dissolution tests. Very valuable to have knowledge of international guidelines EMEA, FDA, ICH, ANVISA and ISO. Experience MS Office and statistical software. Educational milestone: Degree in life sciences, preferably in Pharmacy or Chemistry Preferably Master's degree in Analytical Chemistry and/or Pharmaceutical Industry. Excellent level of English and Spanish, spoken and written. Your key superpowers: Self-sufficient, critical, disciplined, confident, hard-working, creative, motivated, proactive, dynamic, methodical, organized and decisive. Strong analytical and problem-solving skills. Excellent organizational, planning and time management skills in order to design, monitor and enforce work plans. Highly responsible and capable to work under pressure to meet deadlines. Ability to prioritize multiple tasks and execute projects on time in a fast-paced environment. Detail oriented professional with good communication skills. Ability to prioritise multiple tasks and execute projects on time in a fast-paced environment. Ability to use and generate documentation in English. Ability to increase technical knowledge and apply new skills. What makes Galenicum a top-tier workplace? A challenging company, and a dynamic team to work with. A Workspace to enjoy. Pleasant, sustainable, and architecture-awarded office. A flexible schedule to match your preferences and workload. A training offer to learn beyond your job with a broad set of topics: Galenicum Laude. Health insurance coverage to feel cared. Food to keep your energy up. Subsidized meals in our office restaurant Popina. Gym to help you maintain a healthy lifestyle. Flexible remuneration. And, very important! A Buddy to help you land smoothly in our company since day 1. We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you? Come aboard. Believe in life

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