Job title: Commissioning & Qualification Consultant
Company: Katalyst HealthCares & Life Sciences
Job description: Job Description:
The consultant, operating under general guidance, will be responsible for the preparation, execution, review, and approval of commissioning and qualification protocols, reports, and assessments related to equipment, facilities, and utilities. Additionally, the role will involve drafting equipment and material specifications, conduct engineering investigations, and addressing issues associated with equipment and facilities.
Responsibilities:
- 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.
- Lead and contribute to projects of varying complexity, ensuring timely and successful completion of commissioning and qualification activities. Manage personal time and resources effectively to align with departmental and site goals.
- 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.
- Ensure that the qualified state of systems is maintained, and any impacts are addressed in compliance with Lupin’s policies and procedures.
- 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.
- Participate in presenting results to regulatory agencies in collaboration with Lupin Research Inc.
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.
- This position requires a minimum understanding of pharmaceutical regulatory standards.
Expected salary:
Location: Coral Springs, FL
Job date: Wed, 25 Jun 2025 03:37:11 GMT
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