Deviation Writer (Pharmaceuticals)

TL;DR

Deviation Writer (Pharmaceuticals): Managing end-to-end DSP production deviations within the Biologics production process with an accent on field investigations and root cause analysis. Focus on writing technical deviations in the Quality System and defining CAPAs to ensure production compliance.

Location: Onsite in Belgium (presence in production areas required)

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across multiple business lines including Life Sciences and Engineering.

What you will do

• Manage the full lifecycle of Downstream Processing (DSP) production deviations from opening to closure.
• Conduct field investigations through interviews with technicians and operators and by analyzing equipment function.
• Draft and document minor, major, and clustered deviations within the Quality System.
• Collaborate with cross-functional teams, including QA, MSAT, and Maintenance.
• Perform root cause analysis (RCA) and define corrective and preventive actions (CAPA).
• Defend and explain technical analyses to QA and other stakeholders.

Requirements

• 4–6 years of experience in the pharmaceutical or biologics industry.
• Proven track record of end-to-end production deviation writing and management.
• Must be based in or able to work onsite in Belgium to ensure regular presence in production areas.

Culture & Benefits

• Opportunities for rapid growth within a fast-expanding Belgian workforce.
• Work on prestigious projects with renowned clients in biotech and pharma sectors.
• International and dynamic environment promoting intrapreneurship and meritocracy.
• Inclusive workplace committed to diversity and equal opportunity.

Hiring process

• Brief introductory call to discuss motivations and fit.
• Average of 3 interviews with line managers and team members.
• Potential case study or technical assessment depending on the role.