Quality Systems & Compliance Specialist #HDC1

About the role

Join a quality‑focused team responsible for maintaining and strengthening the site’s Quality Management System (QMS). You will ensure compliance with GxP, GMP and other regulatory requirements while supporting cross‑functional quality initiatives.

Key responsibilities

• Develop, review and maintain SOPs, work instructions and other quality procedures.
• Maintain and improve QMS platforms to support GxP compliance.
• Manage site change control activities, including impact assessments and effectiveness monitoring.
• Oversee the CAPA system, ensuring corrective actions are implemented, completed on time and verified.
• Conduct gap assessments against corporate standards and regulatory requirements.
• Handle document and record management, including control, archival and retention.
• Coordinate GMP training, annual training plans and qualification processes.
• Lead product quality reviews, data trending and identification of CAPAs.
• Plan and execute site self‑inspection programmes and support audit readiness.
• Provide quality oversight for supplier management, including agreements and evaluations.

Required profile

• Relevant experience in Quality, Quality Systems, GMP, GxP or a regulated manufacturing environment.
• Strong understanding of QMS, CAPA, change control, document control and audit processes.
• Proven ability to work with cross‑functional stakeholders and manage quality‑related activities.
• Excellent attention to detail, organisational and follow‑up skills.
• Analytical mindset to interpret quality data, identify gaps and drive corrective actions.
• Effective communication and stakeholder management abilities.

Required skills

• GxP compliance
• GMP standards
• CAPA management
• Change control processes
• Document control systems