Date Jul 27 2025 Location Shirwal Pune India Company ACG Group Company ACGE 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 setting 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 Mechanical BOM Review Validate the Mechanical Bill of Materials BOM to confirm inclusion of all installation-critical parts ensuring nothing essential is omitted from dispatch Site Learning Integration Integrate learnings from site installations into factory FAT protocols to continuously improve pre-dispatch testing especially for electrical and mechanical components Software Integrity Pre-Installation Develop robust methodologies to minimize or eliminate the need for software modifications during site installation thereby reducing commissioning time and risk Packing Process Enhancement Re-structure the packing slip format to include equipment Tag Numbers and standardize packing slip generation for better traceability and error reduction Site Issue Resolution Coordination Act as the central point of coordination for resolving factory-originated issues identified at the site enabling immediate corrective actions Key Result Areas Cross-Functional Collaboration Quality at Source Objective Develop and maintain strong trust-based relationships with Cross-Functional Team CFT members including Engineering Manufacturing Procurement Quality Assurance and Project Management to drive a shared responsibility for quality from the very first stage of the product lifecycle Key Results Reduction in quality issues detected during FAT due to upstream corrections Timely resolution of inter-departmental issues affecting FAT readiness Active participation in CFT meetings design reviews and root cause investigations Implementation of design process feedback from FAT into product development Quality Compliance Standardization Objective Ensure full compliance with internal quality standards regulatory requirements ISO GMP etc and customer-specific URS and documentation expectations during FAT Key Results Zero non-conformities in internal audits and customer FATs 100 adherence to SOPs checklists calibration protocols and document validation Reduction in post-dispatch NCs non-conformities due to strict in-process adherence Maintenance of up-to-date records and traceability for all FAT-related activities Process Improvement Efficiency Optimization Objective Continuously identify and implement improvements in FAT processes workflows and testing methods that enhance product quality reduce inspection time and streamline communication without compromising safety compliance or customer satisfaction Key Results Measurable reduction in FAT cycle time through lean process enhancements Implementation of automation or standardization tools in testing and reporting Documented process improvements with quantifiable impact on quality and efficiency Increased number of tests shifted from site to factory I-FAT effectiveness Customer Expectation Alignment Objective Consistently align FAT activities and deliverables with customer-specific requirements and expectations by ensuring transparent communication effective documentation and readiness to handle audits or custom protocols Key Results Positive customer feedback and satisfaction scores during and after FAT Reduction in post-FAT changes or rework requested by customers Increased rate of First Pass customer approvals during FAT Safety and Risk Management Objective Maintain a high standard of safety in all FAT activities ensuring both team members and machinery are protected during testing inspection and pre-dispatch operations Key Results Zero incidents or safety violations during FAT execution Timely implementation of safety recommendations or audit observations Team trained and compliant with updated safety protocols and practices Key Interfaces Internal Interfaces- AE PRD NPD A C PSC PPC Project External Interfaces- Supplier Customer External Auditors If any Third party inspector ISO Auditors Competencies Plant QA understanding Communication Problem Solving Delivering Consistent Results Knowledge of Regulatory Compliance

📌 Lead (Maharashtra)
🏢 ACG Worldwide
📍 Maharashtra