Senior Quality Assurance Leader
vor 3 Wochen
We are excited to present a remarkable opportunity for a Quality Assurance Manager at BioTalent, a leading organization in the healthcare sector, dedicated to pioneering therapies for critical health conditions.
This position is part of the senior leadership team, providing the selected candidate with ongoing professional development and growth in a vibrant and innovative atmosphere.
Key Benefits of This Role
- A strategic role with significant oversight of the quality assurance department
- Acting as the primary contact for all quality assurance matters
- Direct involvement in enhancing site compliance and driving continuous improvement initiatives within a cutting-edge sterile manufacturing environment
- Collaboration with a committed organization that values change and employee development, fostering a positive workplace culture
- Flexible work arrangement with three days onsite
Responsibilities Include
- Effective implementation and oversight of the Quality Management System (QMS)
- Ensuring comprehensive quality compliance throughout the manufacturing facility to meet Good Manufacturing Practice (GMP) standards
- Assisting production with the qualification of equipment and validation of manufacturing processes
- Overseeing Corrective and Preventive Actions (CAPAs), change controls, deviation management, risk assessments, root cause analysis, and equipment validation
- Promoting continuous improvement efforts to cultivate a positive quality culture on-site
- Drafting, reviewing, and approving Standard Operating Procedures (SOPs) and other quality-related documentation, including equipment and process validation
Ideal Candidate Profile
- Extensive experience in a quality assurance role within a pharmaceutical GMP manufacturing setting
- Solid background in manufacturing and quality control
- Proficient in managing GMP audits and familiar with method validation and transfer projects
- Bachelor's degree in a relevant Life Sciences discipline
- Fluency in English and German
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