Manufacturing Operations & Validation Manager

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 :