QA Officer

About Synthon Biopharmaceuticals

Around the world there are still people suffering from diseases for which no adequate medical treatment has been found.

For them we search, research and innovate in some of the world’s most advanced research facilities with the most talented people.

Synthon Biopharmaceuticals focuses on development of innovative medicines, including antibody-drug conjugates, in two key therapeutic areas: oncology and autoimmune diseases.

We provide a fair, human, open and inspiring working environment, with room for ambition, entrepreneurship and new initiatives - leading to innovative medicines with the potential to transform patients’ lives.

Synthon Biopharmaceuticals is based in Nijmegen, the Netherlands, where close to 350 staff work at our state-of-the art biotech campus.

We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.

Job profile

The Synthon Biopharmaceuticals Quality Assurance (QA) organization covers all aspects that could have an impact on the quality of pharmaceutical products and sets clear risk-based expectations on Good Manufacturing Practice and Good Clinical Practice (GMP and GCP). To strengthen our QA product team, which is part of the QA organization of approximately 15 people, we are looking for a QA officer who, together with the team, will ensure GMP quality oversight during manufacture, testing and disposition of (clinical) Monoclonal Antibody and Antibody Drug Conjugate products.

Document review and approval will be a significant part of your daily activities. As a QA Officer you will review and approve (within the established timeframe and according local procedures) documentation from Manufacturing and Quality Control such as Standard Operating Procedures (SOP), Work Instructions (WI), and product related documentation such as Master and Executed Batch Records, raw data records, deviations, changes and Corrective/Preventive Actions. In this role you own the document stream within the QA product group, including archiving, ensuring document traceability and status.

Your profile

  • A bachelor level in biology or life sciences or equivalent.
  • Work experience of 3-5 years as a Quality Officer or similar background, preferably in the biopharmaceutical industry.
  • Extensive knowledge of current Good Manufacturing Practices (cGMP) and data integrity requirements in the biopharmaceutical industry towards operational processes within Quality Assurance, Quality Control and Manufacture.
  • Biotechnological knowledge and experience with development of innovative medicines.

Skills/Capabilities

  • A creative and curious attitude and eagerness to continuously improve products and processes.
  • A can-do attitude, hands-on mentality embracing cross-functional collaboration.
    A team-mindset with excellent communication skills (verbal and written in English and Dutch).
  • Able to identify opportunities for optimization driving Right-First-Time all the time.
    A flexible and pragmatic approach.
  • Accurate, consistent and critical on document review capabilities.
    Demonstrate ownership, highly organized, driven by quality and results.

Important dates

Please send your application before 26 February 2020. The first round of interviews will take place on 5 March 2020 and the second round of interviews will take place on 11 March 2020.

Information and application

Contract hours: At least 32 hours
Salary: depending on experience
Location: Nijmegen

Contact information
For further information, please contact Paul Ballering, Head Quality Assurance at tel. +31 (0)24 372 77 00. If you are interested in joining Synthon Biopharmaceuticals in this challenging position, we welcome your application via the apply button or link, which will directly lead you to our website.

 

Recruitment by commercial agencies in relation to this or other vacancies is not appreciated.

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