Quality Assurance Engineer

About the role

We are seeking a Quality Assurance Engineer to lead deviation management activities within a GMP‑regulated manufacturing setting. The role focuses on ensuring that all quality deviations are investigated, documented, and closed in line with internal procedures and regulatory expectations.

Key responsibilities

• Manage the full deviation lifecycle from initiation through investigation, review, approval, and closure.
• Lead or support root cause analysis and ensure thorough documentation of findings.
• Collaborate with cross‑functional teams to assess quality impact and drive timely closure of deviations.
• Support the development, implementation, and effectiveness checks of CAPA plans.
• Review deviation reports for GMP compliance, accuracy, and completeness.
• Identify recurring deviation trends and contribute to continuous‑improvement initiatives.
• Participate in audits and inspections related to deviation management as required.

Required profile

• Experience supporting regulatory inspections or customer audits.
• Background in sterile manufacturing, biologics, fill‑finish, or pharmaceutical production is a strong advantage.

Required skills