Jobdescription
Title: Quality Specialist
Location: Visp, Valais, Switzerland (On-site)
We are looking for a Quality Specialist with experience in deviation investigations and CAPA management within a GMP-regulated environment – ideally with strong knowledge of processes related to monoclonal antibodies.
This role is critical to ensuring regulatory compliance, preventing recurring issues, and strengthening the quality system through effective corrective and preventive actions.
Responsibilities:
* Conduct thorough and well-documented investigations of deviations in the manufacturing process of monoclonal antibody-based products.
* Perform root cause analyses using structured methodologies (e.g., 5-Why, Ishikawa, FMEA).
* Develop, implement, and follow up on corrective and preventive actions (CAPAs).
* Collaborate closely with teams from Production, QA, QC, and Development to comprehensively address incidents.
* Ensure timely and GMP-compliant handling of all deviations and CAPAs.
* Participate in internal and external audits, including the provision of relevant documentation.
* Contribute to the continuous improvement of the quality management system.
Requirements:
* Completed university degree in Pharmacy, Biotechnology, Chemistry, Engineering, or a related field.
* At least 5 years of experience in a quality function within the pharmaceutical or biotechnology industry, ideally under GMP conditions.
* Solid understanding of monoclonal antibody-related processes.
* Proven experience in deviation investigation and CAPA management.
* Knowledge of international regulations (EMA, FDA, ICH).
* Independent working style with strong analytical and problem-solving skills.
* Excellent English skills, both written and spoken.
Desirable:
* Experience with biological products or biosimilars.
* Familiarity with digital quality management systems (e.g., TrackWise, Veeva).
* Training in continuous improvement methodologies (e.g., Lean, Six Sigma).