Associate QA Clinical Manufacturing

Location: Breda, Noord-Brabant  |  Sector: Biotechnology  |  Start Date: 4/3/2024  |  Job ref: 52509

Associate QA Clinical Manufacturing

The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

Role Description
As an Associate QA Clinical Manufacturing you will be responsible for providing quality oversight in the clinical packaging area and on the Supply Chain of Clinical Trial Products, ensuring compliance with GDP and GMP requirements.

Responsibilities
– Responsible for batch review, to support QP batch certification of Investigation Medicinal Product in compliance with EU regulations.
– Compliance review and approval of clinical label artwork.
– Review and approve deviations, ensuring all the process.
– Review SOP’s ensuring Corporate Site and Regulatory requirements.

Requirements
Master Science degree, in Life Sciences preferable in Pharmacy.
– Typically, 3 years of related experience in QA or manufacturing experience in pharmaceutical or medical device industry.
– Experience in batch record review, investigation and analytical testing.
– GMP , GDP and or GCP knowledge.

Other information
Are you interested? Feel free to contact me!

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About us

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.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.