QA Operations Specialist

About the role

We are looking for a QA Operations Specialist to support Quality Assurance activities at our Geneva manufacturing site. The role ensures that all operations comply with EU and US GMP requirements, as well as Bracco’s corporate Quality and HSE Management System.

Key responsibilities

• Review and release production batch records and packaging batch records.
• Release incoming consumables and ensure compliance with specifications.
• Lead and coordinate investigations of deviations across production, maintenance, packaging, and laboratory functions.
• Define, implement, and follow up on corrective and preventive actions (CAPA) within defined deadlines.
• Investigate complaints and support validation/qualification documentation for sterile production areas.
• Create, review, and update QA Operations documents, SOPs, specifications, protocols, and reports.
• Participate in risk analyses, change control processes, and internal/external audits.
• Provide training for classified areas and evaluate signal detection impacting product quality.
• Communicate quality alerts promptly to Operations Quality Manager and Quality Unit Manager.

Required profile

• University degree in Pharmacy, Chemistry or Biochemistry.
• More than 5 years of experience in Quality Management within a pharmaceutical manufacturing environment.
• Strong knowledge of GMP regulations (EU and US) and sterile production processes.
• Proven ability to lead investigations, manage CAPA, and interact with cross‑functional teams.

Required skills

• GMP compliance
• CAPA management
• Audit execution
• Risk analysis