Specialist QA/QP (Plant QA) (Biotechnology)

Location: Breda, Netherlands; onsite role

Company

hirify.global is a biotechnology company that discovers, develops, manufactures, and delivers human therapeutics.

What you will do

• Act as a Qualified Person and release finished drug product lots in compliance with marketing authorizations and GMP.
• Partner with production staff on risk analysis and establish quality limits and requirements.
• Own, review, and approve SOPs, forms, training materials, test protocols, and other production and Plant QA documentation.
• Review and approve deviations, CAPA, change controls, equipment maintenance work orders, and validation documents.
• Perform GMP compliance checks and lead or participate in investigations, internal audits, regulatory inspections, and partner audits.
• Support GMP training and lead Plant QA projects and global QA initiatives.

Requirements

• Master of Science degree in Pharmacy or an equivalent qualification.
• Thorough knowledge of clinical and commercial manufacturing, GMP, warehousing, supply chain, equipment engineering principles, and validation.
• Knowledge and skills to fulfill the requirements of EU Directive 2001/83/EC, Article 49, for a Qualified Person.
• Practical experience with Good Manufacturing Practice.
• Ability to solve problems and make scientific, risk-based decisions.
• Strong written and verbal communication skills, including technical writing and presentations, with the ability to collaborate with production and technical staff.

Culture & Benefits

• Full-time position within a global biotechnology organization.
• Opportunities to learn and advance across the organization.
• Diverse and inclusive workplace where employees are encouraged to contribute ideas.
• Competitive salary, bonus structure, fixed 13th month, holiday allowance, and collective health insurance.
• On-site gym, vitality program, and restaurant with healthy food.