Quality Assurance Specialist

1 week ago

Navi Mumbai, Maharashtra, India beBeeAssurance Full time ₹ 2,40,000 - ₹ 3,60,000

We are seeking a skilled Quality Assurance Specialist to ensure the quality of our products and services.

Main Responsibilities:
  • Review and prepare qualification documents for GMP software, including MES and other related documents.
  • Prepare URS, GxP risk assessments, qualification protocols (OQ, PQ), RTM, and VSR documents.
  • Review URS, RA, design documents, and qualification documents for accuracy and completeness.
  • Handle post-implementation changes documents and ensure their accuracy and validity.
  • Execute OQ and PQ procedures.
Quality Management System (QMS) Responsibilities:
  • Prepare compliance reports for internal and external audits.
  • Investigate and evaluate change control, CAPA, and deviation issues.
  • Prepare and review SOPs (Standard Operating Procedures).
  • Initiate, investigate, lock, and close TCC, CC, deviation, and incident reports.
  • Verify implemented CAPA and its effectiveness.
  • Prepare PQR/APR reports.
  • Investigate and report on market complaints and product failures at the shop floor.
  • Review GMP documents online.
Document Control Responsibilities:
  • Verify shop floor and online documents.
  • Release finished goods.
  • Prepare, distribute, and retrieve SOPs.
  • Issue documents such as BMR, BPR, and specifications.
Functional Area:

URS, GxP Risk Assessment, Qualification protocols (OQ, PQ), RTM, VSR, MES, GMP, OA, PQ, QMS, CAPA, TCC, CC, PQR/APR, BMR, BPR.

This role requires strong attention to detail, excellent organizational skills, and the ability to work independently in a fast-paced environment. If you have experience with quality assurance, we encourage you to apply.

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