Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing processes, equipment, and systems.
Validate and oversee the performance of IV solution and IV bag manufacturing processes.
Conduct Computer System Validation (CSV) for automated systems and ensure compliance with industry standards and regulations.
Validate filing equipment, ensuring accuracy and efficiency in the production process.
Collaborate with cross-functional teams, including chemistry, automation, and manufacturing, to ensure validated systems meet all requirements.
Maintain detailed validation documentation and reports in compliance with Good Manufacturing Practices (GMP).
Support continuous improvement efforts to enhance process reliability and efficiency.
Requirements:
Bachelor’s degree in engineering, Chemistry, or a related field.
Proven experience in validation processes in pharmaceutical, medical device, or related industries.
Knowledge of IV solution and IV bag manufacturing processes.
Strong experience with Computer System Validation (CSV) and automated manufacturing systems.
Experience with equipment validation, particularly with filing equipment.
Familiarity with GMP, FDA, and other regulatory requirements.
Excellent analytical, problem-solving, and communication skills.
Prior experience in automation, chemistry, and manufacturing environments.
Experience in a highly regulated industry with a focus on quality and compliance.