Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes:
These confirm proper functionality and adherence to operational specifications.
Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products.
Conduct revalidation of equipment and processes when changes occur, such as:
Assess risks related to equipment, processes, and production areas that could impact product quality, safety, or compliance.
Implement corrective and preventive actions (CAPA) to address risks, such as:
Write, review, and execute validation protocols for new equipment, systems, or processes, ensuring documentation meets regulatory and internal requirements.
Archive validation documentation (e.g., validation reports, test results, and corrective action reports) for audits and regulatory inspections.
Document changes in manufacturing processes or equipment and ensure proper validation before implementation.
Train production teams on new validated processes, equipment, and compliance with regulatory and quality standards.
Requirements:
Bachelor’s degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
3 7 years of quality or relevant process experience in a regulatory environment.
Strong communication skills for interaction with cross-functional teams, senior management, and external auditors/regulators.
Familiarity with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems is beneficial.
Strong understanding of validation methodologies, including IQ/OQ/PQ protocols, risk assessments, and data analysis techniques.
In-depth knowledge of FDA and GMP guidelines, as well as Food/Consumer industry regulations.
Proven ability to lead and manage onshore and offshore teams.