Biologics Quality Assurance Specialist
il y a 1 semaine
As part of a project to build a manufacturing site for biomedicines, you will be involved in setting up and managing the Product Quality Assurance department.
Key Responsibilities:- Ensure the reliability of information provided by people involved in the media preparation and material preparation stages.
- Guarantee the conformity of batch records and proceed with their pharmaceutical certification/confirmation.
- Be the main contact for biomanufacturing to ensure the processing of non-conformities and complaints, and for development with a view to the introduction of new products.
- Ensure compliance with Good Manufacturing Practices and the company's Quality Policy.
- Draft and update procedures and monitor regulatory changes within your scope.
- Participate in the recruitment of potential future employees for your department, with the support of the HR department, and ensure their training, skills development and versatility, in line with company policy.
- Collect and escalate data relating to product quality reviews and regulatory files for your scope.
- Report on your scope of activity to your line manager, including updating key performance indicators.
- You are ideally a pharmacist with French recognized diploma and qualified to be registered at section B of the French pharmacist professional board, with at least 2 years' successful operational experience in a pharmaceutical production facility.
- You have a specialization in biotechnologies and/or are familiar with biotechnological industrial production environments.
- You are recognized for your listening and interpersonal skills, as well as for your team spirit. You enjoy taking on challenges and venturing into unexplored fields.
- You have excellent analytical, organizational and summarizing skills, and are highly adaptable and autonomous.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD commercial manufacturing facility in the Seattle area. For job opportunities, learn more at https://www.just-evotecbiologics.com/
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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