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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.
 

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