6 System specialist jobs in Romont found

For our client based in Vaud canton and specialized in biopharmaceutical area, we're looking for a Senior Quality Assurance - CSV specialist 

Responsability

Manage Quality oversight for computerized systems validation and the data integrity program & support QA activities for system introduction/upgrades, ensuring compliance with quality policies, cGMP, EU/US, and Swiss regulations.Oversee daily quality for GxP IT, CSV, and automated systems (SISA).

• Act as the main QA contact for compliance and data integrity
• Review/approve GxP IT, CSV, and SISA SOPs to ensure regulatory compliance.
• Ensure compliance with cGMPs and support Commissioning & Qualification activities.
• Review/approve URS, design documentation, audit trails, deviations, investigations, and CAPA plans.
• Align with Global QA CSV organization and support inspection readiness.
• Collaborate with SMEs to anticipate and handle issues promptly.
• Promote cGMP understanding and application among BioPlant employees.
• Interpret and implement GMP and regulatory requirements.

• Academic degree in natural/applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering).
• Minimum 10 years in CSV/QA CSV with Quality experience.
• In-depth knowledge of cGMP, international regulations, and validation activities.
• Experience with international inspections.
• Strong analytical, problem-solving, and communication skills.
• Fluent in French and English.