Vacature - Jouw nieuwe functie

Specialist QA/QP (Clinical)

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Deel deze vacature

12 FEB ’24: For one of the largest independent biotechnology organisations, committed to discovering the potential of biotechnology for patients with life-endangering diseases, we are currently looking for a Specialist QA/QP (Clinical). This role is especially interesting due to the wide variety of developed molecules in their pipeline, making your exposure to new medicine greater.

Details

Pharmaceutical

Quality/RA

Breda - Netherlands

40 uur per week

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Zo maak jij het verschil

You will provide QA oversight and fulfil QP responsibilities for IMPs received, labeled, packaged and distributed from the facility, to global recipients. You will ensure that quality operations including clinical product release are efficient/effective from both a compliance and business perspective. You aim to establish and maintain effective working relationships with key partners. Furthermore your role includes; Batch record certification on IMPs; Acts as SME for GMP/GDP to SCM, Study Management and Regulatory Affairs, ensuring clinical trial designs are compliant; Lead and assist in quality investigations, approve deviations and CAPA’s, lead and/or participate in audits/inspections; Lead site/global projects and improvement efforts; Review and sign QP-QP agreements, QP declarations, and Quality agreements; Act as delegate for the Sr. Manager Clinical QA in his/her absence.

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Wat jij mee brengt

With a Master's degree in a relevant scientific discipline, being eligible as QP, and broad experience
(5+ years) in (clinical) manufacturing with 3+ years in Quality within biotechnology industry the
right candidate brings along:
  • Strong knowledge of GMP & GDP;
  • Demonstrated experience in investigations, change controls, validations and audits;
  • Fluency in English;
  • Customer-oriented an cultural adaptability, to allow effective collaboration across the globe.

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Jouw voordelen

Partaking on this journey will bring you an employer with strong focus on professional
development, as well as personal flexibility & health benefits. Additionally, the role brings exposure
to several innovative programs. The package for this role consists of:
  • Base salary, tailored to your experience;
  • Bonus (fixed) 10%, with additional variable percentage;
  • LTI option;
  • 25+5 holidays;
  • Health insurance discount as well as private lease discount;
  • Pension plan;
  • Tuition reimbursement budget & in-house fitness center;
  • 1000 EUR budget for hardware (bike/laptop/tablet/etc.).

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