QA Operations Specialist

The company seeks a QA Operations Specialist to support quality assurance activities at its Geneva manufacturing site, ensuring compliance with pharmaceutical GMP standards and corporate quality directives.

This position supports Quality Assurance Operations at the Bracco Suisse SA manufacturing facility in Geneva. The role ensures that all operations meet EU and US pharmaceutical GMP requirements and align with the company's Corporate Quality and HSE Management System. The specialist works under the direction of the Quality Assurance Operations Manager.

Responsibilities

• Examine production batch records for accuracy.
• Approve incoming consumables for use.
• Inspect packaging batch documentation.
• Verify that sterile production quality activities comply with corporate policies and quality directives.
• Oversee deviation investigations across production, maintenance, packaging, and laboratory functions, coordinating with relevant teams.
• Develop, execute, and monitor corrective and preventive actions (CAPA) to ensure timely and effective resolution.
• Investigate customer complaints.
• Review and approve validation and qualification documentation for sterile production areas.
• Create, review, and maintain QA Operations documents.
• Approve GMP documents for production areas, including SOPs, specification protocols, and reports.
• Collaborate with cross-functional teams to conduct risk analyses.
• Participate in the change control process.

Requirements

• University degree in Pharmacy, Chemistry, or Biochemistry.
• Minimum of five years of experience in Quality Management within the pharmaceutical industry.
• Strong understanding of current Good Manufacturing Practices (cGMP), including Annex 1.
• Hands-on experience with lyophilized products and aseptic processing.
• Experience in indirect management of projects or investigations.
• Fluent proficiency in both French and English, written and spoken.

What the company offers

• Join a successful, well-established company with advanced manufacturing facilities and promising growth prospects.
• Access to professional development opportunities to apply and expand your expertise.
• Competitive salary packages complemented by comprehensive benefits.

About the company

Bracco is a global healthcare group specializing in diagnostic imaging and recognized as a market leader in the field. The company distributes its primary products, contrast agents, across more than 100 countries through various channels including direct sales, joint ventures, and distribution agreements. The Geneva manufacturing site, approved by major regulatory bodies such as the FDA and Swissmedic, produces lyophilized contrast agents for international export.

• Operates as a global leader in diagnostic imaging.
• Manufacturing facilities meet strict regulatory standards from agencies like the FDA and Swissmedic.
• Focuses on producing high-quality contrast agents for global distribution.