Quality Assurance Validation

2 weeks 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 :


  1. Engineer (Mech/Elec/Chem) with 10-14 years of experience in Validation of Biopharma / Sterile Process Equipment's.
  2. Has knowledge of Validation processes and Regulatory requirements, including ISPE C&Q Vol 5, GAMP 5, 21 CFR Part 11, EU Annex 11 and other PIC/ICH guidelines and GxP.
  3. Understands and has Prepared documents like URS, DQ, FAT-IOQ / SAT-IOQ.
  4. Has Knowledge of reviewing DQ Engineering drawings like --- P&ID, GA, 3D, SA, EGA etc.
  5. Has Hands-on experience in running cycles of CIP, SIP, Biopharma processes and Clean Utilities.
  6. Is aware of ASME BPE Code, more specifically, stipulations for Dead Leg and Slope.
  7. Has Hands-on experience in Calibrating Field Instruments typical of Biopharma processes for liquid/air Flow, pH, Conductivity, Level, Volume, RPM, Load Cell etc.
  8. Has Experience in Diagnosing, Rectifying and Preparing Non-Conformance Reports (NCRs) arising during pre-FAT and FAT in Collaboration with cross-functional Teams to ensure the effective execution of FAT activities.
  9. Has Experience in Preparing, Executing and Customer-Approving Qualification Documents.
  10. Possesses excellent Communication and Customer Management skills.


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.

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