Our client is the leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders.
You will be mainly responsible for the the qualification/validation of the facility, equipment, automation and processes. You will also be the primary contact for Quality related issues in the project.
-Setting GMP standards and provide Quality oversight for Qualification and Validation of facilities, utilities, equipment and processes
- Quality oversight for Computer System Validation (CSV), including Data Integrity
- Ensure compliance with all regulatory requirements in relation to the pharma industry and HSE legislation and cGMP requirements
- Review and approve the outcome of Quality Investigations and Corrective/Preventive actions
- Lead or assist in GMP Risk Assessments and ensure that risk-mitigations are implemented.
- Acts as quality SME (Subject Matter Expert) for regulatory submissions and inspections in the area of responsibility.
- Proven experience in a Quality role in the pharma or biotech industry
- Min. of 4-6 years of experience working in a GMP environment
- Preference for a Quality role in Qualification and Validation work
- Broad experience in QMS (Change controls, deviation management, others)
Are you ready to the next step in your career? Fill out your application by using the apply button