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QA Operations Specialist

QA Operations Specialist

LocationBern, Switzerland
Business SectorBiotechnology
Contact email
Job ref22117
Publishedabout 1 month ago

Our client is a prominent biotech company, known for its innovations in the field of rare diseases. They are currently seeking a dynamic Quality Assurance Operations Specialist to join their growing team in Switzerland.


Key Responsibilities:

  1. Regulatory Compliance: Implement, monitor, and maintain the quality management system to ensure compliance with regulatory requirements, including GMP and ISO standards.
  2. Operational Excellence: Collaborate with cross-functional teams to streamline and optimize operations, driving efficiency while maintaining the highest standards of quality.
  3. Audits and Inspections: Prepare for and assist with internal and external audits, ensuring adherence to compliance standards and addressing any findings or discrepancies.
  4. Documentation Control: Oversee document management, including SOPs, batch records, and quality records, to guarantee accuracy, completeness, and compliance.
  5. Risk Management: Identify and assess potential risks in operational processes, working to mitigate and manage them effectively.
  6. Training and Development: Provide training and support to employees regarding quality standards, procedures, and best practices, ensuring a culture of quality awareness.
  7. Deviation and CAPA Management: Lead investigations into deviations, non-conformities, and incidents, implementing corrective and preventive actions (CAPAs) to prevent recurrence.
  8. Change Control: Manage change control processes to assess and approve changes in operations and maintain compliance.



  • Bachelor's or Master's degree in a relevant life sciences discipline.
  • Minimum of 5 years of experience in quality assurance within the biotech or pharmaceutical industry, with a focus on oncology.
  • In-depth knowledge of regulatory requirements and quality standards, specifically in the field of oncology.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities.
  • Experience with document control and audit preparation is a plus.



Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.


?: +41 (0) 44 5514 407

?: c.kelly@panda-int.com