Katalyst Healthcares and 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:
- ssess 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.
- rchive 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.
- 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.