Key Responsibilities:

• Ensure production equipment and systems comply with all required quality standards, specifications, and regulatory frameworks (URS, FAT, SAT, IQ, OQ, PQ).
• Execute validation activities for manufacturing processes and equipment.
• Review and approve validation protocols, reports, and plans.
• Oversee and support change control processes related to validated systems.
• Conduct and document Quality Risk Assessments (QRA).
• Analyze quality data and communicate results effectively across departments.
• Ensure alignment with GMPs, SOPs, and applicable regulatory guidelines.
• Participate in and support Quality Engineering project management initiatives

Requirements & Qualifications:

• Proven experience in quality validation within a regulated manufacturing environment (pharmaceuticals, biotechnology, or related industries preferred).
• Good knowledge of validation lifecycle including URS, FAT, SAT, IQ, OQ, PQ.
• Experience with quality systems, change control, and QRA methodologies.
• In-depth understanding of GMP regulations, quality standards, and industry best practices.
• Excellent analytical, documentation, and communication skills.
• Ability to work collaboratively with cross-functional teams including Quality Assurance, Engineering, and Production.

Benefits

• Work in a friendly and challenging environment
• Competitive salary
• Private insurance
• Personal development opportunities