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Senior Quality Assurance Specialist

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Deel deze vacature

5 JAN '24: For a Leiden-based organisation comprising a state-of-the-art facility and expert knowledge on the development, production, and commercialisation of Cell and Gene Therapies, we are currently looking for a Senior QA Specialist. They help academic and industrial developers enter the clinical stage by combining the required expertise in a brand-new development & GMP manufacturing facility.

Details

Biotechnical

Quality/RA

Leiden - Netherlands

40 uur per week

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Zo maak jij het verschil

The Senior QA Specialist will ensure that the GMP activities and Pharmaceutical Quality System of the organisation are compliant with the applicable legislation, guidelines and/or their own quality expectations, while pursuing continuous improvement. The Senior QA Specialist advises employees, contractors and clients on QA-related matters, acting as second in line next to the Head of Quality. Other tasks include effective and timely handling of quality issues (deviations, complaints) and monitoring the application and efficiency of corrective and preventive actions. Furthermore, you'll be ensuring that GMP relevant changes are monitored and well documented in the QMS (change controls). Last but not least, you will support the creation of SOPs, policies and the audit program.

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Wat jij mee brengt

As a strong Senior QA Specialist professional, you will recognise yourself in the following:
  • MSc in Biotechnology, chemistry, biopharmaceutics, or equivalent;
  • Proficient in cGMP, GDP, and regulations promulgated by the EMA or equivalent regulatory agencies;
  • Eight years of recent experience in (bio)pharmaceutical environment with at least five years of recent experience in Quality Assurance;
  • Experience within a sterile manufacturing environment, preferably ATMPs (biologicals, vaccines, injectables, parenteral);
  • Good communication skills in English (verbally and written);
  • Willingness to travel: Occasional trips are needed for audit program support.
 

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Jouw voordelen

As a Senior QA Specialist, you will receive a competitive salary and a very beneficial pension plan. Not to mention the many opportunities and exciting dynamics of a scale-up environment in Leiden its Bioscience park. A standard full-time position at this organisation is 36 hours. In addition to your salary, you will receive:
  • A 13th-month payment and an 8% holiday allowance;
  • The unique opportunity to co-define the organisation and contribute to the organisation's establishment;
  • Your expertise is critical for their successful further scaling, meaning you will enjoy a lot of responsibility and impact regarding key decisions.

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