QA Specialist – Deviation Support

About the role

We are seeking an experienced QA Specialist to lead deviation management within our Quality Control laboratories. The role focuses on ensuring GMP compliance, data integrity, and timely resolution of laboratory deviations in a regulated biotech setting.

Key responsibilities

• Review and approve deviations linked to QC laboratory activities.
• Lead and support investigations, including root‑cause analysis.
• Maintain compliance with GMP, ALCOA+ data‑integrity principles, and internal procedures.
• Collaborate closely with QC teams to resolve quality issues effectively.
• Provide clear guidance and challenge stakeholders when necessary.
• Ensure timely completion of deviation handling to meet project deadlines.

Required profile

• Degree in a life‑sciences discipline.
• Minimum 5 years QA experience in a GMP‑regulated pharmaceutical or biotech environment.
• Detail‑oriented with strong analytical thinking.
• Self‑driven, adaptable, and able to manage deadlines in a fast‑paced environment.
• Effective communicator across teams and stakeholders.

Required skills

• Experience with electronic QMS (eQMS) platforms.
• Familiarity with ERP systems such as Veeva, TrackWise or SAP.
• Solid understanding of GMP regulations and ALCOA+ data‑integrity principles.
• Knowledge of QC laboratory processes and technical documentation.