Quality Control Analyst (m/f/d)

Tasks :

• Perform QC analyses and sample collections in compliance with SOPs, cGMPs, and pharmacopoeial standards

• Complete documentation (forms, logbooks, results systems) per Good Manufacturing and Documentation Practices

• Notify supervisors of non-conforming/invalid results and initiate quality events within deadlines

• Proactively report planning deviations and escalate procedural deviations as required

• Comply with and promote EHS rules; address unsafe behaviors and open EHS events promptly

• Participate in maintaining a safe, compliant lab environment during all activities

• Execute validation and qualification protocols for methods, systems, equipment, and consumables

• Perform recalculations, supervise external results, and reconcile controlled documents

• Ensure equipment calibration/maintenance is current and report any issues.

• Conduct GEMBAs, review alarms, and uphold 5S lab organization standards.

• Train analysts and apprentices on equipment and GMP; act as a backup trainer

• Maintain up-to-date training status (e.g., SABA) and complete modules on time.

• Act as SME for methods/equipment, resolving complex issues and supporting CAPAs

• Back up supervisor or QC lifecycle roles and contribute to risk analyses and regulatory submissions

• Manage logbooks, trend reports, and data systems (RAM, Bolton) with strong data integrity focus

• Assess result validity/conformity and escalate priority conflicts as needed.

• Support and initiate corrective and preventive actions in collaboration with lab leadership

Qualification:

• Minimum CFC (Swiss Federal Certificate) in microbiology or equivalent experience in the pharmaceutical or biotech industry.

• 2–5 years of experience in a cGMP lab or minimum 2 years as Analyst I.

• At least 5 years of experience in a cGMP lab or minimum 5 years as Analyst II

• Good to excellent knowledge of lab methods.

• Good understanding of cGMP requirements.

• Knowledge of Data Integrity and its application in a regulated environment.

• Comfortable with standard office and IT tools (MS Office suite).

• French and technical English required.

• English level: minimum B2

Start : 21.07.2025