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Batch Review/Release officer
Temporary three months contract for a project in batch record review for drug substance
Het bedrijf / The company
This organisation is a contract manufacturing organisation located at the Bioscience Parc in Leiden. They provide service in manufacturing for commercial products as well as clinical products. They have an open and professional culture where everyone is working hard, but also finds time to have some fun. They recently took on a project for which they have to expand their Quality Department. This is why the organisation would like to hire new professionals to help out.
De functie / The role
As the Batch Review/Release Officer you will be involved in the project for producing the COVID-19 vaccine in a large manufacturing site. For now it will be a temporary project where you will work with a team to manage and improve the process following government and organisational quality guidelines. Your main responsibility and focus is to get the quality approval for drug substances of batch record review. It is also your responsibility to prepare, evaluate and follow-up a monthly management review. Therefore, you will write and approve procedures and work instructions. You will keep track of the management of Quality Agreements with service providers and subcontractors, as well as management of (internal) audits and inspections. You will develop QA training materials and train others on QA topics and address vendor qualification. Furthermore, you will act as a QA-lead for the project teams and as a QA-contactperson for the client on a day to day basis. You will lead project-related quality records and review master and batch record and related raw data. You will also act as an internal Quality Consultant on applicable regulations and related topics. The preparation to release packaging for disposition by the Qualified Person is also a responsibility.
Het profiel / Your profile
• bachelor’s degree in Life Sciences (Biotechnology or related) or comparable level through experience
• minimum of three years working experience within a GMP- or CMO environment
• hands-on experience in pharmaceutical operations or a laboratory is a preference
• knowledge of European and US’ rules and regulations on GMP
• experience with pharmaceutical quality management systems
• experience with Lean management and 6 Sigma methodology
• good knowledge of Dutch and English in speaking and writing, German is advantageous
• excellent technical writing skills
Het aanbod / The offer
• a challenging project to keep up with the quality standards
• working in a multicultural project team
• the office is located in Leiden
• a temporary position for two to three months, with the possibility to extend
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-129-FMF, to Sandra van Putten: email@example.com.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.