What are the responsibilities and job description for the GMP Compliance Consultant position at Katalyst HealthCares and Life Sciences?
Job Overview
Katalyst HealthCares and Life Sciences is seeking a highly skilled GMP Compliance Consultant to join our team. The ideal candidate will have a strong background in validation within the pharmaceutical industry, particularly in decommissioning of facilities, equipment, and systems.
Key Responsibilities:
- Develop and execute validation plans for manufacturing, laboratory, and packaging systems.
- Lead qualification and validation activities for new and existing systems.
- Conduct risk assessments and ensure proper risk mitigation strategies are in place.
- Provide expertise in Good Manufacturing Practice (GMP) and regulatory guidelines for validation processes.
Requirements:
- Bachelor's or master's degree in engineering, Life Sciences, Chemistry, or related field.
- Proven experience (typically 5 years) in validation within the pharmaceutical industry, with a focus on equipment, systems, and process validation.
- Demonstrated experience with decommissioning of pharmaceutical facilities, equipment, and systems.
- Strong knowledge of regulatory requirements, such as FDA, EMA, ISO 13485, and GMP.
- Experience with validation lifecycle documentation (e.g., protocols, reports, and risk assessments).
- Familiarity with computerized systems validation (CSV) and data integrity principles.
