
QC Tech Transfer, Qualification & Validation Specialist
About the role:
As a QC Specialist you will be responsible for ensuring that our processes and products comply with applicable quality standards and regulations. You will be a key player in the management of analytical method development and validations, as well as collaborating with cross-functional teams to optimize our analytical methods. Your experience in method validation will be critical to drive continuous improvement and ensure operational excellence.
Key Tasks:
- Contribute to the development of new methodologies and improvements in validation processes.
- Collaborate with cross-functional teams to optimize analytical methods and resolve technical issues.
- Write and review validation protocols for analytical methods.
- Perform data analysis and evaluation to ensure compliance with guidelines.
- Maintain accurate records of validation activities and ensure proper documentation.
- Train other team members in validation practices and regulatory compliance.
Key Working Relation:
- Reports functionally to QC TT, Qualification & Validation Expert.
- Quality departments.
- Project Management and Bussiness Development.
- Operations (Manufacturing, R&D, MSAT).
Skills & Qualifications:
- Degree in Biological Sciences, Engineering or related field.
- Deep knowledge of analytical methods in one or more of the following areas: molecular biology (qPCR, dPCR, sequencing), biochemistry (ELISA, CE-SDS), physicochemistry (HPLC).
- Minimum of 3 years of laboratory experience developing and executing analytical assays.
- At least 1 year experience working in GMP environment and in analytical method validation.
- Knowledge of applicable quality standards and regulations.
- Proficient in both written and spoken English.
- Exceptional attention to detail, reliability and ability to work in a regulated environment.
- Excellent problem solving and analytical skills, with a data-driven approach to decision making.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Company Values: Humility, Empathy, Responsibility, Commitment, Teamwork and Effort.
We Offer:
- Stable contract with a 4-month trial period.
- A dynamic and collaborative work environment.
- Opportunities for professional development and continuous training.
- Direct impact on the development of therapies that improve people's lives.
- Additional benefits; health insurance, flexible working hours, possibility to work remotely (hybrid), etc.
