Quality Analyst (EN/FR)

Bilingual Quality Analyst

Join a dynamic team in Switzerland dedicated to laboratory excellence and regulatory compliance within the pharmaceutical industry. This role focuses on quality control, particularly in the cardiovascular therapy area, requiring hands-on experience with biochemical laboratory methods and a strong understanding of cGMP standards. You will play a key role in ensuring compliance, conducting analyses, and supporting continuous improvement initiatives.

Responsibilities

• Perform biochemical analyses and supervise activities in accordance with laboratory procedures and GMP/BPD rules.
• Prepare laboratory solutions for analyses.
• Adhere to all current procedures and EHS regulations.
• Accurately complete forms, logbooks, and documentation following Good Manufacturing and Documentation Practices (ALCOA).
• Notify the supervisor of non-conforming or invalid results promptly and initiate quality system events within deadlines.
• Manage laboratory investigations and troubleshoot minor issues within your expertise.
• Execute protocols for reagent qualification, consumables validation, and equipment/method validation.
• Ensure calibration and maintenance of equipment during analysis.
• Maintain real-time Kanban management and report procedural deviations.
• Organize and maintain the laboratory according to 5S standardization norms.
• Support continuous improvement initiatives.

Key Skills and Requirements

• Educational background in biology, biochemistry, or a related scientific field (CFC or equivalent).
• Experience in a QC laboratory environment under cGMP standards.
• Proficiency in techniques such as electrophoresis, HPLC, ELISA, or enzymatic activity determination.
• Fluency in French and technical proficiency in English.
• Swiss/EU nationality or valid Swiss work permit.
• Experience in drafting method validation protocols is a plus.