Quality Assurance Validation

6 days ago

Pune, India DD Enterprises Full time

Job Title: QAV Lead


Education Qualification: Bachelor’s degree in Mechanical/ Instrumentation Engineering, or a related field


Years of Experience: 8 to 10 years


Overview:


We seek a results-driven, high-achiever to join our QAV team, with a robust professional knowledge base and a flexible, adaptable approach to new technologies, processes, and operating systems. The ideal candidate should have a passion for meeting key performance indicators (KPIs) quantitatively and qualitatively. The incumbent will assist the QAV Manager in fostering a healthy, competitive team atmosphere and providing objective feedback on any slippages or errors in expected deliverables and performance. Aptitude for excellence and surpassing benchmarks is essential. Industry Experience in QA, validation, or a related field, especially within regulated industries (e.g., pharmaceuticals, biotechnology).


Accountable and Responsible for :


  • Technical Documentation and Requirements:

- Execute the Technical Offer, URS, Purchase Order, and DQ File of the project.

- Ensure receipt and study of all relevant documents, data, and information from the Project and Production Team.

  • Pre-FAT and FAT Documentation:

- Ensure receipt and study of all Pre-FAT and FAT documents/data from the QA Team, including approved protocols and drawings (P&ID, GA, 3D, Electrical Drawing, Weld Map).

  • Quality Control Coordination:

- Coordinate with the QC Team and verify the Inspection Release Note (IRN) of the vessel before commencing mechanical checks.

  • Installation and Utility Tie-In/Tie-Out Checks:

- Perform and verify the P&ID walkdown on the system.

- Conduct utility tie-in/tie-out checks.

- Verify the system for overall completion.

- Make a list of deviations/issues and communicate them to respective internal stakeholders.

  • Continuous Improvement:

- Perform, verify, and document deviations and shortcomings.

- Collaborate with the QA Team to address and resolve issues.

  • Piping and Mechanical Components:

- Ensure all piping and mechanical components are connected as outlined in the P&ID.

- Verify the correctness of the piping installation, ensuring pipe fittings match face-to-face connections.

- Highlight P&ID with GREEN if all components are correctly connected. Use ORANGE to indicate any discrepancies.

  • Physical Damage Inspections:

- Inspect the system for any physical damage, dents, or disfigurations.

- Document and list all deviations.

  • Instrument Installation Verification:

- Confirm all instruments are installed as illustrated in the P&ID.

- List any missing instruments.

- Use the ERP system to verify the availability of instruments/components.

- Generate a requisition for missing components and ensure their issuance.

- Install instruments/components as per the approved P&ID.

  • Tagging Verification:

- Verify that tag stickers are applied to valves, instruments, and components as per the approved P&ID.

  • Dimensional Checks:

- Perform installation and dimensional checks referring to Pre-FAT and FAT protocols.

- Verify all drawings of GA & 3D and ensure accurate utility tie-in/tie-out.

  • Mechanical Checks:

- Conduct mechanical checks as per approved Pre-FAT and FAT protocols, including:

- Hydrostatic Pressure hold test.

- Set pressure test for Safety Relief Valve.

- Spray Ball Coverage (Riboflavin) Test.

- Drainability Test.

  • Electrical Team Coordination:

- Ensure the Electrical Team completes all electrical connections/components in the system:

- Pneumatic tube laying and termination.

- Correct valve tag ferrules on every pneumatic tube.

- Wire termination for instruments such as Load Cells, Temperature Transmitters, Pressure Transmitters, Light Source, and Sensors (pH, DO, Conductivity, etc.).

- Proper power supply connections with appropriate earthing.

- Cable/wire dressing considering safety and aesthetics

  • Internal Coordination and Follow-Up:

- Ensure constant follow-up and coordination with respective internal stakeholders to address and close any identified deviations or issues.

- Ensure & Close follow-up from respective Internal Stakeholders for Post Pre-FAT and FAT Compliance.

- List & Submit Short Supply, if any, to the Projects Team for listing and submission.

- Pack and Dispatch the System by following the approved Sequential Workflow Protocol for this activity.

  • Review & Archive As-built Project deliverables, including:

- P&ID (Piping and Instrumentation Diagrams)

- GA (General Arrangement drawings)

- 3D models

- SA (System Architecture)

- RL (Red Line markup drawings)

- EGA (Electrical General Arrangement)

- EA (Equipment Arrangement)

- VM (Valve Matrix)

- FDS (Functional Design Specifications)

- SDS (Software Design Specifications)

- HDS (Hardware Design Specifications)

- ISO drawings

- Data Sheets

- DQ/IOQ/SAT Protocols


Technical Skills:

1. Knowledge of Regulatory Standards: Familiarity with GMP (Good Manufacturing Practices), FDA regulations, ISO Standards, and other relevant guidelines.

2. Validation Techniques: Proficiency in various Validation methodologies and documentation.

3. Risk Management: Experience in Risk assessment practices.


Soft Skills:

1. Attention to Detail: Precision and accuracy in conducting Validation activities and documentation.

2. Communication Skills: Excellent verbal and written Skills for clear and effective reporting and collaboration.

3. Problem-Solving: Strong analytical Skills to identify issues and implement corrective actions.


Key Attributes:

1. Attention to Detail and quality orientation

2. Strong Problem-Solving abilities

3. Ability to manage multiple tasks and projects simultaneously

4. Effective Communication and interpersonal Skills

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