MSAT EM Expert

KPC International - Excellence from Concept to Completion

MSAT EM Expert (Subject Matter Expert)

The MSAT EM Expert is a Subject Matter Expert (SME) role with deep expertise in environmental qualification, manufacturing environments, analytical testing, and product knowledge. This role leads Environmental Monitoring (EM) Performance Qualification (PQ) activities and ensures compliance with applicable regulatory and quality standards.

Key Responsibilities

• Lead Environmental Monitoring (EM) Performance Qualification (PQ) activities, ensuring effective communication and alignment between all stakeholders and adherence to approved EM PQ SOPs.
• Oversee and, where required, execute validation activities, ensuring documentation is clear, scientifically sound, and compliant with EU GMP, ISO 13485, and 21 CFR Part 820 requirements.
• Develop comprehensive project plans, including accurate timelines and budget assessments.
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