The Company
Our client is a leading global organization within the pharmaceutical industry, recognized for its commitment to excellence and innovation. They specialize in the development and production of high-quality medicinal products. Their dedication to maintaining the highest standards of quality and compliance is evident across all levels of their operations, making them a trusted name in the field.
Role Description
We are seeking a detail-oriented Quality Assurance Specialist to join our client's team. The ideal candidate will have strong communication skills and the ability to work effectively under pressure. Experience with Good Manufacturing Practices (GMP) is highly desirable. This role is crucial in ensuring the accuracy and compliance of SAP Master Data and artwork for medicinal products. The Quality Assurance Specialist will work closely with multiple departments, including the Global Artwork Center, Master Data, SCPM, Site SMEs, RA department, and QA Management.
Key Responsibilities
– QA Review & Approval: Conduct thorough reviews and approvals of SAP Master Data activities, including critical value verification and Bill of Materials.
– Artwork Approval: Oversee the approval process for artwork related to medicinal products, ensuring all materials meet regulatory and company standards.
– Documentation: Act as the author and reviewer for operational SOPs and Work Instructions, ensuring all documentation aligns with regulatory requirements.
– Metrics and Performance: Prepare and maintain weekly and monthly performance metrics, and manage departmental performance boards.
– Cross-Functional Collaboration: Participate in QA-related projects and investigations as needed, contributing to the continuous improvement of QA systems.
Qualifications
– Education: MBO or Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and experience. This role is also suitable for entry-level candidates with a Master's degree in Life Sciences.
– Experience: Typically, 3 years of experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry.
– GMP Knowledge: Familiarity with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP), with the ability to apply these principles in routine cases.
– Language Skills: Fluency in English is required; proficiency in Dutch is preferred.
Additional Information
This is an excellent opportunity for a quality-focused professional looking to contribute to the production of life-saving medicines within a supportive and innovative environment. If you are passionate about ensuring the highest standards of quality in pharmaceutical production, we encourage you to apply.
Looking forward to chatting with you!
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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.
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