Specialist QA

Your new company
Join a leading global biopharmaceutical organisation dedicated to improving patients' lives through the development, manufacturing, and distribution of innovative healthcare products. The company operates in a highly regulated GMP environment and is committed to quality, compliance, and continuous improvement. This position is based within a dynamic production quality team, working closely with Production, Engineering, Warehouse, and Quality stakeholders.
Your new role
As a CW Specialist QA, you will provide quality oversight and support for equipment, automation, and information system validation activities within a highly regulated pharmaceutical manufacturing environment. You'll work closely with Engineering, Manufacturing, and IS teams to ensure compliance with corporate, site, and regulatory requirements.
Key Responsibilities:• Perform QA support and oversight for equipment, automation, and information system validation activities.• Review and approve validation documentation to ensure compliance with corporate, site, and regulatory requirements.
• Provide guidance to operational teams on GMP compliance, quality policies, standards, and procedures.
• Support validation strategies, quality investigations, and quality engineering initiatives.
• Review and approve equipment modifications, engineering changes, and maintenance-related procedures.
• Act as QA representative in Quality Risk Management activities, including pFMEA, QRAES, and computer system compliance assessments.
• Review and approve quality risk assessments and summary reports.
• Perform final QA review of technical change controls and ensure stakeholder assessments are complete.
• Function as QA Subject-Matter Expert (SME) for validation, risk management, and change control activities.
• Support device and combination product quality requirements while ensuring GMP compliance.

What you'll need to succeed
• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent.• 5-8 years of experience in a GMP-regulated pharmaceutical environment.
• Proven experience with Equipment Validation, Automation Validation, and Computer System Validation.
• Strong knowledge of Annex 11, 21 CFR Part 11, GMP regulations, and data integrity requirements.
• Experience using risk management tools such as FMEA and other quality risk methodologies.
• Experience with CAPA, Non-Conformance Management, and Change Control processes.
• Strong analytical and problem-solving skills with the ability to evaluate complex situations.
• Excellent communication skills and ability to collaborate across multiple departments.
• Strong technical writing and documentation review skills.
• Ability to apply a risk-based approach to decision-making and quality oversight.

What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. An extension to stay within the department is anticipated. In this position, you will get a competitive salary starting at €5700 bruto per month and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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