Deviation Specialist – GMP Investigations

About the role

The Deviation Specialist will support a large‑scale mammalian cell‑culture facility within a regulated biotechnology environment. You will own quality deviations, lead investigations, determine root causes, assess product and system impact, and drive corrective and preventive actions to completion.

Key responsibilities

• Take ownership of quality deviations and document investigations in accordance with cGMP.
• Lead cross‑functional investigations, collaborating with Subject Matter Experts to identify root causes using structured methodologies.
• Assess the impact of deviations on product quality and manufacturing processes.
• Define, implement and verify CAPAs to prevent recurrence.
• Represent the Operations Unit and ensure investigations meet regulatory requirements.
• Contribute to continuous‑improvement initiatives and maintain compliance.

Required profile

• Bachelor’s degree in Chemistry, Biotechnology, Life Sciences or a related field.
• Experience conducting deviation investigations in a regulated pharmaceutical or API environment.
• Strong knowledge of cGMP principles and quality investigation processes.
• Proven ability to work with SMEs and cross‑functional teams.
• Excellent technical writing, presentation and communication skills in English.

Required skills

• cGMP compliance
• Fault Tree Analysis
• Defense Analysis
• Event & Causal Factors Chart
• Fishbone Diagram
• CAPA development and effectiveness checks
• Root‑cause analysis methodologies