Qualification Specialist - Equipment Integration (GMP)

Katalyst Healthcares and Life Sciences

Philadelphia, PA

Responsibilities:

Develop and implement qualification strategy for digital equipment in line with GMP and regulatory requirements.
Create and execute qualification plans/protocols, ensuring proper documentation and compliance.
Conduct risk assessments and implement mitigation strategies.
Collaborate with cross-functional teams on testing and qualification activities, especially with QA SMEs.
Maintain accurate and up-to-date validation documentation (plans, reports, protocols, change controls).
Drive continuous improvement of qualification processes and stay updated on regulatory trends.
Act as an interface between business and IT teams to lead scoping and stakeholder discussions.

Requirements:

Strong understanding of lab systems lifecycle models and end-user business applications.
Expertise in qualification principles and practices in a GMP-regulated environment.
Experience with qualification of digital solutions, including release management processes.
Knowledge of infrastructure management across multiple product releases.
Excellent communication and stakeholder management skills.

Apply

Vacancy posted 1 day ago

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