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Specialist QA/QP (GMP)

13 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 (GMP). 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 hours per week

Get to know

Your consultant

Sander Westerhout

+31 6 51 66 69 96 s.westerhout@qtcrecruitment.com

About your role

This is how you will make the difference

You’ll provide QA oversight and fulfill QP responsibilities for medicines received, labeled, packaged and distributed from the facility to global recipients. You'll guide Production, Maintenance & Engineering, and Quality staff to maintain top-level quality standards, ensuring efficient product release. As part of our team, you'll lead/contribute to projects shaping the future of quality assurance. Moreover you will: Release labelled and packed products for different markets; Partner with production, SCM, and engineering to guide Quality and establish standards; Own, review, and approve production and quality-related documentation; Review/approve deviations and CAPA, and perform impact assessment for change controls; Contribute to continuous improvement projects and drive digital innovation; Participate/lead in internal audits and regulatory inspections; Assist in the development/delivery of GMP training for quality and production.

what's needed

What you bring

With a Master's degree in a relevant scientific discipline, being eligible as QP, and broad experience (5-7 years) in pharmaceutical manufacturing in a QA related position, the right candidate brings along:

Extensive knowledge and practical experience of GMP & GDP regulations;
Knowledge and skills to fulfil the requirements of EU Directive 2001/83EC article 49 (Qualified Person);
Demonstrated experience in investigations, change controls, validations and audits;
Fluency in English;
Strong communicator with extensive intercultural understanding, allowing effective international collaboration.

What we offer

What's in it for you

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, 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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This is how you will make the difference

What you bring

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