Senior QA Specialist – Clinical Operations

Location: Breda, Noord-Brabant  |  Sector: Biotechnology  |  Start Date: 1/16/2024  |  Job ref: 52157

The Company
This company is a biotechnology pillar of the world, committed to transforming new ideas and discoveries into medicines to treat serious diseases. Its goal is to create innovative medicines, provide transformative research, and high-quality treatment worldwide. They are contributing to a better world by focusing on people, society, and the planet.
Role Description:
As a QA Senior Associate in Clinical Production and Warehouse, your primary responsibility will be to ensure quality assurance oversight in the clinical production arena. Moreover, you will play a crucial role in supporting quality processes associated with the warehousing of both clinical and commercial products, both on-site and at outsourced partners. This position requires direct engagement with various stakeholders and entails the establishment of effective working relationships with key parties, including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production, and Site Quality.
Responsibilities:
-Conduct batch reviews to support the QP batch certification of Investigational Medicinal Product, ensuring compliance with EU and international regulations.
-Perform checks on finished products during production runs and ensure GMP compliance in production processes.
-Assist in resolving compliance and quality issues associated with manufacturing and warehousing.
-Oversee quality assurance for both internal and external warehouses, including compliance checks, damage inspections, distribution complaints, and temperature data review.
-Take ownership of generating operational SOPs and Work Instructions.
-Review SOPs to ensure alignment with Corporate, Site, and Regulatory requirements.

Requirements:
MBO or bachelor’s degree in Life Sciences or a related field, or an equivalent combination of education and experience.
-Typically possesses 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry, including expertise in batch record review, investigations, and analytical testing.
-Knowledgeable in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP).

Other Information
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

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