Requirements: English
Company: Recordati Group
Region: Milan , Lombardy
Join to apply for the Quality Assurance Specialist CMO role at Recordati.With its beginnings in a family-run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and a turnover of over Euro 2bn.We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors, and the people across the globe who we serve. We develop and commercialize medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.At Recordati, our mantra is simple. Weve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest we want to give people the opportunity to be the best version of themselves.This drive will never stop. Together, we will always be reimagining tomorrow with new ideas, new technologies, and new innovations to fight diseases.Job PurposeWe are looking for a candidate with a significant experience of at least 5 years in the Quality Assurance of a pharmaceutical company to manage third-party production.Key ResponsibilitiesManage process validation activities;Manage the change control system;Draft Risk Assessments;Conduct investigations and draft related reports;Review Analytical Methods/Specifications;Manage inspections by regulatory authorities and clients;Conduct audits of raw material suppliers and packaging materials, as well as pharmaceutical contractors, in Italy and abroad;Draft and review Quality Agreements.Required SkillsProcess validation;Change control;Risk Assessment drafting;Investigation and related reporting (deviations and/or complaints);Review and manage the flows of the Analytical methods and specifications;Review and manage the flows of the Master Batch Records;Participation in client audits or regulatory inspections;Carry out audits of suppliers (raw materials, packaging materials, and CMO), in Italy and abroad;Draft and review Quality Agreements.Required EducationDegree in Chemistry, Pharmacy, Biotechnology, or similar.Required Skills And ExperienceSkills in medical devices, cosmetics, and food supplements are welcome.Technical CompetenciesGood knowledge of multiple pharmaceutical forms production processes is appreciated; in particular, a good knowledge of the sterile injectable forms is required.Required LanguagesKnowledge of the English language, written and oral, is required.Travel required in %At Recordati, we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.We are proud to be an equal opportunity employer. We recruit, develop, and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionMarketing and SalesIndustriesPharmaceutical Manufacturing#J-18808-Ljbffr