Senior Quality Assurance Specialist

vor 2 Wochen


Orbe, Waadt, Schweiz Randstad Vollzeit
Job Description

We are seeking a Senior Quality Assurance Specialist to join our team at Randstad. The ideal candidate will have a strong background in quality assurance and a deep understanding of computerized systems validation and data integrity.

Responsibilities

As a Senior Quality Assurance Specialist, you will be responsible for managing quality oversight for computerized systems validation and the data integrity program. You will also support QA activities for system introduction/upgrades, ensuring compliance with quality policies, cGMP, EU/US, and Swiss regulations. Additionally, you will oversee daily quality for GxP IT, CSV, and automated systems (SISA).

Key Responsibilities

  • Act as the main QA contact for compliance and data integrity
  • Review and approve GxP IT, CSV, and SISA SOPs to ensure regulatory compliance
  • Ensure compliance with cGMPs and support Commissioning & Qualification activities
  • Review and 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


Requirements

The ideal candidate will have an academic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering) and a minimum of 10 years of experience in CSV/QA CSV with quality experience. They will also have in-depth knowledge of cGMP, international regulations, and validation activities, as well as experience with international inspections. Strong analytical, problem-solving, and communication skills are also essential. Fluency in French and English is required.

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