Our client, a leading player in the field of precision medicine, dedicated to delivering innovative solutions that improve patient outcomes, are in search of a meticulous Quality Assurance Specialist. This person will have a pivotal role in upholding quality standards and ensuring compliance in our client's precision medicine projects and products.
- Quality Management: Establish and maintain a robust quality management system in alignment with industry standards and applicable regulations.
- Regulatory Compliance: Stay updated on relevant regulatory requirements and ensure all quality processes comply with them.
- Quality Audits: Conduct thorough internal and external audits to identify areas for improvement and verify adherence to quality standards.
- Document Control: Oversee document control systems to ensure the accuracy and currency of documentation.
- Risk Assessment: Identify, assess, and mitigate potential risks associated with product quality and safety within the precision medicine context.
- CAPA Management: Manage corrective and preventive action (CAPA) processes, including root cause analysis and implementation of corrective measures.
- Supplier Quality: Evaluate and manage supplier quality, including conducting supplier audits and ensuring compliance.
- Quality Training: Develop and deliver training programs to enhance the quality awareness of employees within a precision medicine setting.
- Quality Metrics: Establish and monitor key performance indicators (KPIs) related to quality and provide regular reports to management.
- Bachelor's degree in a life science field (e.g., biology, genetics, biotechnology).
- Minimum of 4 years of experience in quality assurance, with a preference for expertise in biotech and precision medicine.
- Strong knowledge of regulatory requirements in the biotech and precision medicine sectors.
- Exceptional analytical, problem-solving, and communication skills.
- Quality auditor certification is a plus.
- Ability to work collaboratively in an interdisciplinary team focused on precision medicine.
Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.
?: +41 (0) 44 5514 407