QA Systems Specialist – CMMS (Quality & Compliance)

About the role

An experienced QA Systems Specialist is needed to support quality oversight across Quality Control and drug substance manufacturing. The role focuses on reviewing and approving maintenance and calibration records within a regulated biotech environment.

Key responsibilities

• Review and approve CMMS work orders for maintenance and calibration activities.
• Ensure alignment with GMP, data integrity, and internal quality standards.
• Support deviation handling, including investigation and root‑cause analysis.
• Collaborate closely with QC, manufacturing, and engineering teams.
• Provide clear feedback to stakeholders and challenge where required.
• Ensure timely completion of quality activities to meet deadlines.

Required profile

• Detail‑oriented with a high level of accuracy.
• Self‑driven and proactive.
• Able to manage deadlines in a fast‑paced environment.
• Strong communicator across functions and stakeholders.

Required skills

• Hands‑on experience with CMMS systems.
• Familiarity with eQMS and ERP platforms such as Veeva, TrackWise, or SAP.
• Solid knowledge of GMP and data‑integrity principles (ALCOA+).
• Strong technical writing and documentation abilities.