What are the responsibilities and job description for the Regulatory Compliance Specialist position at Katalyst HealthCares and Life Sciences?
About the Role
We are seeking a highly experienced Regulatory Compliance Specialist to join our team at Katalyst HealthCares and Life Sciences. 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, execute, and maintain validation protocols and reports for equipment, systems, processes, and software.
- Lead qualification and validation activities for manufacturing, laboratory, and packaging 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.
This is an excellent opportunity for a motivated individual to join our team and contribute to the success of our organization. If you are a results-driven professional with a passion for regulatory compliance, we encourage you to apply.
