The Deviation Specialist will support a large-scale mammalian cell culture facility by owning and investigating deviations to ensure compliance, product quality, and continuous improvement.

Type of employment: Payroll

Project start:

Tasks:

• Own, document, and investigate deviations in alignment with cGMP requirements.
• Collaborate with SMEs and stakeholders to determine root causes and assess product/system impact.
• Apply structured investigational tools (e.g., Fishbone, Fault Tree, Event & Causal Factors).
• Define effective CAPAs and associated effectiveness checks.
• Drive timely closure of quality records and support process improvement initiatives.

Qualifications:

• Bachelor’s degree in chemistry, biotechnology, life sciences, or related field.
• Experience with deviations and cGMP in pharma/API is a strong advantage.
• Knowledg...