Job Summary
We are looking for a Senior QC Equipment Qualification Specialist / Lead to manage qualification, lifecycle management, and decommissioning activities for Quality Control laboratory equipment within a GMP-regulated manufacturing environment.
This role will take ownership of qualification strategy, project execution, documentation compliance, risk management, and stakeholder coordination across laboratory equipment lifecycle activities. The successful candidate will act as a senior technical contributor and coordination lead, working closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure equipment systems remain compliant, audit-ready, and aligned with site and regulatory expectations.
Your Missions
Own and manage equipment qualification lifecycle activities including IQ, OQ, PQ, requalification, periodic review, and decommissioning where applicable.
Define project strategies, implementation plans, timelines, risk mitigation approaches, and resource coordination for qualification and decommissioning projects.
Author, review, and approve qualification protocols, reports, SOPs, risk assessments, traceability matrices, and training materials.
Provide technical guidance on deviations, investigations, CAPA, change control, and impact assessments related to laboratory equipment and qualification processes.
Review validation and qualification documentation to ensure compliance with GMP, GDP, data integrity, and regulatory expectations.
Partner closely with QC, Validation, Engineering, Quality Assurance, IT, and external vendors to drive timely and compliant project execution.
Monitor project milestones, risks, dependencies, action items, and implementation progress to ensure delivery within timelines.
Your Profile
Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline.
10+ years of experience in equipment qualification, validation, commissioning, lifecycle management, or compliance within GMP-regulated manufacturing or laboratory environments.
Solid understanding of GMP, GDP, data integrity, validation lifecycle, change control, deviation, CAPA, risk assessment, and audit readiness requirements.
Proven experience authoring, reviewing, and leading qualification protocols, reports, SOPs, risk assessments, validation plans, and related compliance documentation.
Familiarity with analytical or laboratory equipment such as continuous flow analysers, nitrogen analysers, TOC systems, gas generators, analytical balances, microbalances, or similar laboratory instrumentation would be an advantage.
Strong stakeholder management, project coordination, documentation review, and technical problem-solving skills.
What We Offer
