Laboratory Analyst

Description

Position Summary: We are seeking an analytical laboratory professional to develop and control processes under regulatory guidelines, ensuring quality and reliability. Key Highlights: 1. Development and validation of analytical methods in accordance with regulations 2. Management of analytical equipment and preparation of technical reports 3. Teamwork and problem-solving in a global environment We are looking for a professional for the analytical laboratory area to join our team and actively participate in the development and control of processes under regulatory guidelines. **Key Responsibilities:** Develop, transfer, and validate analytical methods in accordance with current regulatory requirements. Update and maintain standard operating procedures (SOPs) and analytical techniques. Organize and coordinate stability studies, including trend analysis. Investigate, document, and follow up on out-of-specification (OOS), out-of-trend (OOT), and out-of-expectation (OOE) results. Monitor laboratory project timelines and activities, ensuring proper execution. Manage calibration and qualification of analytical equipment, guaranteeing its availability and reliability. Prepare technical reports in Spanish and English, with high accuracy and clarity. As a global healthcare company, Fresenius Kabi is Committed to Life. Our products, technologies, and services are used in the therapy and care of critically ill and chronically ill patients. With more than 55\.000 employees worldwide and presence in over 100 countries, Fresenius Kabi’s broad product portfolio focuses on providing access to high-quality, life-saving medicines and technologies. In Clinical Nutrition, we offer a comprehensive portfolio of enteral and parenteral nutrition products that make a significant difference in patients’ nutritional status. In MedTech, the company provides essential infusion pumps, cell and gene therapy devices, medical supplies, and more. Furthermore, Fresenius Kabi is a world leader in the supply of blood collection bags and devices, supporting blood banks and healthcare centers globally. Our portfolio of generic injectable drugs and intravenous infusion therapy solutions helps save millions of lives each year in areas such as emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi adopts an integrated approach to healthcare, combining expertise, knowledge, innovation, and commitment, impacting the lives of nearly 450 million patients annually. With its Vision 2026 strategy, as part of \#FutureFresenius, the company continues developing, manufacturing, and marketing new products and technologies, aiming to strengthen its position as a global leader in therapies, improve healthcare delivery, and generate sustainable value for its stakeholders, contributing to the future of health. Requirements University degree in Chemistry, Biochemistry, Pharmacy, or related field. Proven experience in analytical method development and validation. Solid knowledge of stability studies and regulatory requirements (ICH, GMP). Advanced proficiency in technical English (reading, writing, and communication). Proficiency in laboratory software and data management tools. Proactivity and organizational skills. Effective communication skills and strong interpersonal abilities. Results-oriented mindset and ability to meet deadlines. Teamwork and problem-solving capabilities. Benefits Company-provided lunch Birthday leave day 21 vacation days Discount at Sportclub chain