Our client is a global health care company that delivers innovative health solutions through its prescription medicines, vaccines, biologic therapies, and animal health products. It`s first European branch opened in 1954 in Amsterdam and now has three other facilities in the Netherlands serving more than 140 countries
Our client is a leader in Biotechnology Operations in Oss. They are seeking a highly motivated and experienced Quality Operations Specialist to join their dynamic Quality Operations (QO) team. As a key member of the QO department, you will play a pivotal role in ensuring the highest standards of quality and compliance in the manufacture, packaging, testing, storage, and distribution of MMD products.
–Quality Strategy: Develop and implement the quality supplier strategy in alignment with global guidelines.
Manage Supplier agreements, focusing on Quality Agreements, and handle changes with suppliers.
Collaborate with internal departments (Global Procurement, SD&PM, BQOEM, QA, Q-IPT) and external entities to ensure compliance with quality procedures and legislation.
Participate in site audits, regulatory inspections, and lead improvement projects.
–Compliance: Initiate, revise, and monitor area procedures to ensure compliance.
Participate in Quality Area projects for process improvement and lean processes.
Communicate major observations to management and lead change initiatives.
Ensure the clients compliance systems are always up to date.
–Guidance: Participate in cross-functional/global teams to provide guidance.
Support day-to-day problem-solving activities and global troubleshooting efforts.
–Administrative: Monitor and ensure a compliant level of documents and data.
Provide support for Quality Notifications, CAPAs, and Change Control.
–EHS Responsibility: Actively contribute to the realization of the corporate policy on safety, health, and environment.
Demonstrate a personal commitment to working safely, healthily, and environmentally friendly.
-At least 5 years of relevant experience in the pharmaceutical industry and cGMP.
-Minimum bachelor’s degree (HBO/HLO) in Science or a relevant field.
-Experience with quality and compliance guidelines and manufacturing processes.
-Technical knowledge in manufacturing/packaging processes and testing techniques.
-Proficiency in Technical Writing, Root Cause Analysis, FMEA, CAPA establishment, and Lean Six Sigma.
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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.
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