Quality Assurance Specialist – Deviation Investigation

About the role

Coalesce Management Consulting is expanding its Quality Assurance team. The QA Specialist will lead deviation investigations across engineering‑related events, ensuring timely closure and compliance with site procedures and regulatory expectations.

Key responsibilities

• Lead end‑to‑end deviation investigations for engineering, production, MSAT, validation and quality events, adhering to QMS requirements and timelines.
• Collaborate with subject‑matter experts to gather data, assess impact and define investigation strategies.
• Evaluate the effectiveness of corrective and preventive actions (CAPAs) and recommend improvements.
• Track deviation lifecycle milestones, communicate progress and raise escalations when needed.
• Identify trends in deviations, CAPAs and recurring issues to drive continuous improvement.
• Maintain accurate, inspection‑ready documentation within electronic quality management systems.
• Participate in investigations related to equipment performance, utilities, process interruptions, automation and engineering projects.

Required profile

• Experience in pharmaceutical, biotechnology, medical device or other regulated manufacturing environments.
• Background supporting internal audits, regulatory inspections and continuous‑improvement initiatives.
• Strong interpersonal and communication skills with the ability to work collaboratively across all levels.

Required skills

• Electronic Quality Management System (eQMS) usage.
• CAPA management and assessment.