Senior Quality Assurance - CSV specialist
Senior Quality Assurance - CSV specialist
Jobdescription
Profile
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.
Profile
- 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.
Margot Ferraton
Über die Firma
