Senior Quality Assurance - CSV specialist.

  • Orbes
  • veröffentlicht am 8. Oktober 2024
  • läuft am 31. Januar 2025 ab
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Job Details

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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.

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.

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Margot Ferraton

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