Do you want to be part of a worldwide organization recognized as the World's Best Workplace with the mission of saving patients through advanced biotech technologies? Our client's products reach over 10 million patients worldwide, which is why we are supporting them in looking for a Senior Quality Validation Specialist to oversee the validation of equipment, automation, and information systems, as well as Quality Risk Management.

Responsibilities

• Provide QA oversight and support for validation of equipment, automation, and information systems, along with Quality Risk Management activities.
• Review and approve validation documentation, ensuring compliance with GMP, corporate, site, and regulatory requirements.
• Define validation strategies and provide guidance on equipment, process, automation, and system design, characterization, and validation.
• Review and approve equipment changes, parameter modifications, and engineering assessments.
• Review and approve Maintenance & Engineering procedures, including preventive and corrective maintenance processes.
• Manage device and combination product quality responsibilities and ensure compliance with GMP regulations.
• Represent QA in Quality Risk Management activities, including pFMEA, risk assessments, and computer system compliance reviews.
• Review and approve quality risk assessments and ensure alignment with corporate quality policies and strategies.
• Perform final QA review of technical change controls and coordinate QA input for change assessments.
• Support quality investigations, testing strategies, and operational teams on quality standards, policies, and procedures.

Requirements

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology, or a related discipline.
• 4-8 years of experience in a GMP-regulated pharmaceutical or life sciences environment.
• Hands-on experience with equipment, automation, and information systems validation.
• Strong knowledge of GMP regulations and computerized system compliance requirements (e.g., Annex 11, 21 CFR Part 11).
• Experience with Quality Risk Management tools, including FMEA and other risk assessment methodologies.