summary.

Orbes
Permanent

specialism
life sciences
contact
Margot Ferraton
reference number
20497

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job details

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.

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

+41 58 201 54 41
Geneva Professionals Health Care & Life Sciences

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Senior Quality Assurance - CSV specialist.

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Margot Ferraton

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