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Senior QA Specialist

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15 SEP '23: This Leiden-based organisation comprises a state-of-the-art facility and expert knowledge on the development, production, and commercialisation of Cell and Gene Therapies. They help academic and industrial developers enter the clinical stage by combining the required expertise in a brand-new development & GMP manufacturing facility. They enable the next generation of therapies by translating research programs into actionable health solutions for patients.




Leiden - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

We are currently recruiting for a Senior QA specialist who 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 also employees, contractors and clients on QA-related matters. 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 other QA related documentation.

QTC logo icon what's needed

What you bring

As a strong Quality professional, you will recognise yourself in the following:
•    MSc in Biotechnology, chemistry, biopharmaceutics, or equivalent;
•    Proficient in CGMPs, GDPs, 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

•    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.

With the competencies:
•    Thorough;
•    Self-organised;
•    Detail-oriented;
•    Problem-solving;
•    Co-operative;
•    Teamwork skills.

QTC logo icon What we offer

What's in it for you

As a Senior QA Specialist, you will receive a competitive salary and an excellent pension plan. Not to mention the many opportunities and exciting dynamics of a scale-up environment and GMP training by our expert team. 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 launch, meaning you will enjoy a lot of responsibility and impact regarding key decisions. 

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