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If you are a Quality professional who enjoys working in dynamic environment and you are looking for a meaningful career opportunity where you would be responsible for implementation and improvement of aspects of Technical Research and Development (TR&D) Quality Assurance in a fast-growing biotech company, this role might be the right opportunity for you.
In this role you will build a TR&D QA team, closely interact with the TR&D team, and provide quality support for TR&D activities. Further you will contribute to the establishment of a global Quality Management System fit for purpose for TR&D.
- Implement a phase appropriate Quality Management System for Technical Research and Development (TR&D) in Utrecht in close alignment with the Polpharma Biologics Group standards;
- Define and map quality processes for TR&D activities;
- Provide Quality Oversight for TR&D projects (process and analytical) according to Good Development Practices;
- Provide technical quality input on all TR&D relevant matters to support TRD project initiatives;
- Performance of consistency checks across TR&D for regulatory relevant source documents;
- Oversee equipment and software qualification, validation and release, ensure that Data Integrity requirements are met;
- Management of QMS in the TRD department, including QA management of activities such as quality events, change control, documentation management systems and archiving, supplier management, training, and self-inspections;
- Preparation and execution of audits & inspections, and act as Subject Matters Expert as appropriate (authorities, partners, customers);
- Master’s or PhD degree in a relevant field (medicines, pharmacy, biotechnology, biochemistry, chemistry);
- Over 5 years of Quality Assurance experience preferably in TR&D or MS&T in pharmaceutical or biotechnological company. Experience in cell line development or cooperation with CMO in the field of Cell line development or in GMP manufacturing of cell banks would be an advantage;
- Experience in risk-based approaches;
- Deep knowledge of pharmaceutical quality system and data integrity requirements;
- Experience with quality audits and inspections;
- Deep knowledge of EMA, FDA and other relevant regulations;
- Strong skills and willingness to work and communicate cross-functionally and across sites;
- Ability to work adapt to the company and local culture;
- Very good command of English language, very good command of Dutch would be an advantage;
- Ability to cooperate with others to solve problems;
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.