Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Ensure that all finished products are manufactured, packaged, and labeled in compliance with legal and regulatory requirements.
Ensure raw materials, components, in-process materials, and finished products meet quality and regulatory specifications.
Collaborate with QA teams to ensure manufacturing processes align with the company’s Quality Management System (QMS).
Oversee the validation of manufacturing equipment, systems, and processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP guidelines.
Lead qualification of new equipment, ensuring adherence to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Ensure software and IT system validation for Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.
Develop and implement validation plans, protocols, and reports, ensuring they meet regulatory standards and company policies.
Identify and implement process validation (PV) strategies to enhance efficiency, quality, and compliance in manufacturing.
Oversee re-validation activities when process or equipment changes occur to maintain compliance.
Lead Corrective and Preventive Actions (CAPA) by addressing deviations, conducting root cause analyses, and ensuring timely resolution of issues.
Manage validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs), in accordance with regulatory requirements.
Lead and manage onshore and offshore teams, ensuring they are well-trained, motivated, and aligned with company goals.
Provide mentorship and guidance to manufacturing and validation teams, fostering a culture of compliance and operational excellence.
Work with training departments to ensure that teams receive proper training on procedures, regulatory compliance, and equipment handling.
Requirements:
Bachelor’s degree in engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
5 10 years of experience in quality, manufacturing operations, and validation in a regulated industry (pharmaceuticals, medical devices, or food manufacturing).
3 8 years of leadership experience, with the ability to manage onshore and offshore teams.
Strong understanding of regulatory requirements including FDA 21 CFR Part 820, GMP, and ISO 13485.
Experience in process validation (PV), equipment qualification (IQ, OQ, PQ), and software validation.
Ability to lead cross-functional teams, interact with senior management, and liaise with regulators or auditors.
Strong analytical, problem-solving, and continuous improvement mindset.
Excellent communication and leadership skills to manage teams and drive compliance.
Manufacturing operations, validation (IQ, OQ, PQ, PV), regulatory compliance (FDA, GMP, ISO).
Pharmaceuticals, medical devices, food manufacturing.
Leadership, problem-solving, cross-functional collaboration, regulatory communication.
MES, ERP, quality management systems (QMS), validation documentation tools.