Lead - Mechanical QA

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 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.
• 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

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