Job Objective- To lead and manage the Final Inspection and FAT (Factory Acceptance Testing) processes for granulation line machinery. This includes supervising and guiding the FAT team to ensure all machines are inspected, tested, and verified strictly in accordance with the Customer's URS (User Requirement Specification) and internal quality standards. The role involves ensuring that all functional, mechanical, electrical, and software aspects of the machine meet performance expectations before dispatch. Additionally, act as a technical expert during FATs, representing the company in front of customers, addressing their queries, and ensuring a successful sign-off. Primary responsibilities- Functional- Quality Assurance Expertise: Demonstrate a comprehensive understanding of quality assurance (QA) processes, ensuring all FAT activities align with company standards, customer requirements, and regulatory norms. FTR (First Time Right) Implementation: Collaboratively lead the FAT team to achieve First Time Right execution across each stage of inspection and testing, minimizing rework and enhancing process efficiency. Execution & Problem Solving: Plan and execute FAT activities in accordance with project timelines. Identify operational challenges during FAT and inspection and proactively develop and implement effective solutions. Customer & Third-Party Handling: Serve as a subject matter expert for handling customers, Third Party Inspectors (TPI), and internal stakeholders during FATs, ensuring clarity, confidence, and satisfaction throughout the inspection process. Customer Complaint Analysis & CAPA Support: Lead the analysis of customer complaints, contribute to root cause analysis (RCA), and support the development and implementation of Corrective and Preventive Actions (CAPA) to ensure continuous product improvement. Continuous Improvement Initiatives: Drive and contribute to continuous improvement efforts by identifying process gaps and implementing changes that enhance FAT quality, reduce testing time, and ensure operational excellence. Technical Clarifications: Consult with Managers or Project, Engineering, Automation Heads for clarification on discrepancies related to part specifications, drawings, or documentation to ensure issues are resolved before FAT execution. Documentation & Compliance Knowledge: Maintain sound knowledge of qualification protocols, certifications, calibration procedures, and regulatory documentation required for successful FAT execution in a pharma environment. Pharma Equipment & Testing Expertise: Possess deep understanding of pharmaceutical machinery and their standard functional testing procedures, including compliance with cGMP, GAMP, and 21 CFR Part 11 requirements. Audit & Compliance Standards: Be familiar with standard auditing methodologies (e.g., ISO, ASME) and apply non-destructive testing (NDT) procedures as required during inspection. Cross-functional FAT Collaboration: Collaborate with cross-functional teams to highlight and resolve issues that may affect on-site installation and commissioning, ensuring all concerns are addressed prior to dispatch. Site Readiness Optimization (I-FAT): Ensure installation readiness by executing effective Internal FATs (I-FAT) at the factory, thus minimizing site installation time and reducing resource wastage. Validation Document Review: Review and verify all validation and qualification documentation during I-FAT, ensuring alignment with customer expectations and regulatory compliance. Site Issue Resolution Coordination: Act as the central point of coordination for resolving factory-originated issues identified at the site, enabling immediate corrective actions. CAPA Team Participation: Actively participate in the CAPA team by providing technical insights and support for comprehensive root cause analysis of site issues. Spare Parts Coordination: Oversee and coordinate the spare parts dispatch process from the factory, ensuring timely availability and accuracy. Manual Development: Lead the development and localization of Indian versions of Operation, Installation, and Control Manuals for machinery and associated accessories. Pre-dispatch Inspection: Collaborate with the dispatch team to conduct final pre-dispatch inspections, ensuring all machines are shipment-ready and compliant. Supply Chain Coordination: Coordinate with procurement, stores, and planning teams to eliminate short or false supply issues and ensure complete, accurate shipments to customer sites. Key Result Areas- - Cross-Functional Collaboration & Quality at Source - Quality Compliance & Standardization - Process Improvement & Efficiency Optimization - Customer Expectation Alignment - Safety and Risk Management Qualification - BE Mechanical Experience - 8 to 12 years Location - Shirwal Transport facility will be provided
