Quality Assurance Specialist (GMP)
SIRE® Life Sciences
Quality Assurance Specialist (GMP)
Samenvatting
Wat krijg je?
Wat ga je doen?
- Conduct quality reviews of artwork documents
- Review and approve SAP master data
- Ensure adherence to GMP standards
- Approve artwork for medicinal products
- Draft and review operational SOPs
Wat verwachten wij?
- Bachelor degree in Life Sciences or related field
- 3 years experience in pharma or medical devices
- Experience with SAP master data and critical values
- Resident within one hour drive of Breda (pre)
Volledige vacaturetekst
This leading organization in the life sciences industry focuses on delivering safe, effective products through rigorous quality management. As a Quality Assurance Specialist, you will play a vital role in reviewing artwork and SAP master data within a dynamic GMP environment. Enjoy the benefit of specialized training on SAP systems while building cross-functional relationships. Take this chance to elevate your QA expertise and contribute to vital compliance projects. Explore your potential in Breda and help shape the future of healthcare today!
Company
We are representing a leading organization in the life sciences industry, dedicated to ensuring the highest standards of quality and compliance across their manufacturing processes. Their focus is on delivering safe, effective products through rigorous quality management and continuous improvement.
Job Description
We are seeking a detail-oriented Quality Assurance Specialist with a GMP background to join their team on a temporary basis. This role involves reviewing artwork and master data to ensure compliance with quality standards. The position offers an excellent opportunity for those looking to develop their QA skills within a dynamic environment, with potential for longer-term employment.
Responsibilities
- Conduct quality reviews of artwork and associated documents for regulatory compliance and accuracy.
- Review and approve SAP master data, including critical values and Bill of Materials.
- Ensure adherence to GMP standards and internal quality systems.
- Prepare, evaluate, and approve artwork for medicinal products.
- Draft and review operational SOPs and work instructions.
- Participate in QA projects and investigations as needed.
- Maintain and monitor quality metrics, and update departmental performance boards.
- Establish and nurture effective working relationships with cross-functional teams such as Artwork, Master Data, Regulatory Affairs, and QA management.
- Support continuous improvement initiatives and problem-solving processes related to data integrity and compliance.
Requirements
- Bachelor's degree or higher in Life Sciences or a related field.
- Approximately 3 years of QA or manufacturing experience within the pharmaceutical or medical device industry.
- Strong understanding of GMP, GDP, and GCP regulations.
- Excellent attention to detail and accuracy.
- Fluent in English; Dutch language skills are a plus but not mandatory.
- Ability to learn new systems quickly, with training provided for SAP and artwork review processes.
- Willingness to commit to an initial six-month contract with no immediate guarantee of permanent employment.
- Willing to work onsite for 3-4 days during training and 2 days afterwards, with a preference for candidates residing within an hour’s drive of Breda.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59203
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