Job title: Commissioning & Qualification Consultant
Company: Katalyst Healthcares & Life Sciences
Job description: Responsibilities:
- The duties listed below provide an overview of the primary responsibilities. The consultant may be required to undertake additional duties as necessary to fulfill the role.
- Author, review, approve, and execute commissioning and qualification documents, including protocols for Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across various equipment, facilities, and utilities.
- Coordinate all necessary activities related to the execution of commissioning and qualification deliverables.
- Collect and manage all data obtained during commissioning and qualification, ensuring data integrity for use in Good Manufacturing Practice (GMP) decision-making processes.
- Assess the impact of changes to qualified systems and implement best practices in validation to continuously enhance the site’s validation program.
- Assist in troubleshooting and resolving deviations or failures identified during the commissioning or qualification of critical equipment, facilities, or utilities, ensuring product quality and patient safety.
Requirements:
- Associate degree with a minimum of 1 years of relevant experience.
- Strong understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
- Extensive knowledge of 21 CFR 211, 21 CFR 820, Part 11, and applicable ISO standards.
- Familiarity with ISPE Guidelines is preferable.
Expected salary:
Location: Coral Springs, FL
Job date: Fri, 18 Oct 2024 06:48:32 GMT
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