Associate Director Quality Assurance

2 weeks ago


Noida, Uttar Pradesh, India Le Human Resources Solutions Pvt. Ltd. Full time
Job DescriptionPosition Overview

Reporting to the VP Quality, the Associate Director Quality Assurance will be responsible for leading the Quality Assurance team to ensure the delivery of high-quality products.

Key Responsibilities:

  • Develop and implement Quality Management Systems to ensure compliance with GxP regulations.
  • Lead Internal Audits to verify the adequacy of CSV deliverables and Documentation.
  • Review and provide feedback on Validation Plans, Test Plans, and Qualification Scripts.
  • Collaborate with the Engineering Team to resolve CAPA and RCA issues.
  • Ensure Sampling of 25% of artefacts for audits.

Requirements:

  • BE/ B.Tech./ MCA/M. Pharma or equivalent degree from a recognized institute.
  • Minimum 15-20 years of experience in Software Development, Product Implementation, and CSV.
  • Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, and ALCOA + principles.
  • Lead Auditor certification on ISO 9001:2015 and ISO 27001:2013.

Preferred Qualifications:

  • Excellent communication and leadership skills.
  • Experience with documentation authoring, reviewing, and requirement analysis.

How to Apply:

Interested candidates can submit their resumes to shruti@hrworksindia.com.



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