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Senior QA Specialist
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.
Biotechnical
Quality/RA
Leiden - Netherlands
40 hours per week
Get to know
Your consultant
About your role
This is how you will make the difference
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
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.
• Thorough;
• Self-organised;
• Detail-oriented;
• Problem-solving;
• Co-operative;
• Teamwork skills.
What we offer
What's in it for you
- A 13th-month payment and an 8% holiday allowance;
- The unique opportunity to co-define the organisation and contribute to the organisation's establishment.
Send your application