Quality Specialist, Randstad

Randstad

Location:

Switzerland, Visp

Category:

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

This role is critical to ensuring regulatory compliance, preventing recurring issues, and strengthening the quality system through effective corrective and preventive actions.

Job Responsibility:

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

Nice to have:

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)

Additional Information:

Job Posted:

March 31, 2025

Expiration:

May 31, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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