Quality Assurance Specialist
SIRE® Life Sciences
Quality Assurance Specialist
Samenvatting
Wat krijg je?
Wat ga je doen?
- Onderzoeken van afwijkingen en CAPA's ondersteunen
- Kwaliteitsbewustzijn binnen de productielocatie bevorderen
- Optreden als kwaliteitsvertegenwoordiger bij projecten
- Afdelingen ondersteunen bij GMP-praktijken
- GMP-documentatie beoordelen en goedkeuren
Wat verwachten wij?
- Degree in pharmacy, engineering or life sciences
- Experience as Quality Assurance or Release Officer
- Knowledge of GMP standards
- Experience with packaging technology and quality control (pre)
Volledige vacaturetekst
At this leading pharmaceutical facility in Haarlem, you will contribute to the global distribution of over 2,500 medicines. As a Quality Assurance Specialist, you play a pivotal role in the batch release process, collaborating closely with integrated process teams and the vaccination packaging unit. Within this dynamic environment, you act as a quality representative for innovative projects and new product introductions. Ready to impact global health? Explore the full details of this vital position.
Company:
A leading pharmaceutical manufacturing facility based in Haarlem, dedicated to distributing over 2,500 different medicines and vaccines to more than 140 countries. The organisation operates through integrated process teams and centres of excellence, ensuring high standards of quality and compliance across its global supply network.
Job Description:
We are looking for a detail-oriented Quality Assurance Specialist to join our client’s team. The role involves supporting the quality release process for pharmaceutical products, ensuring all batches meet rigorous quality standards, and maintaining compliance with regulatory requirements. The position offers an opportunity to work within a dynamic team in a fast-paced manufacturing environment.
Responsibilities:
-Review and support investigations into deviations, complaints, and corrective and preventive actions (CAPAs).
-Contribute to fostering a strong culture of quality awareness within the Haarlem production site.
-Act as the quality representative in various projects, especially during the introduction of new products.
-Assist different departments with GMP practices and implementing change controls.
-Review and approve GMP documentation such as SOPs, validation/qualification reports, and change control records.
-Collaborate closely with the vaccination packaging team, quality control laboratories, and Qualified Persons to ensure batch release procedures are followed accurately.
-Support ongoing quality assurance activities and participate in ongoing quality improvements.
Requirements:
-Bachelor’s or master’s degree in pharmacy, chemical engineering, life sciences, or a related field.
-Several years of experience as a Quality Assurance or Quality Release Officer, or relevant internship experience during a master’s degree in pharmaceutical manufacturing.
-Knowledge of GMP standards.
-Experience with packaging technology and quality control is advantageous.
-Familiarity with SAP is a plus.
-Strong teamwork, communication, and interpersonal skills, with the ability to work independently.
-Fluency in Dutch and English, both spoken and written.
Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59188
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