Quality Assurance Specialist

3 hours ago


Noida, Uttar Pradesh, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000
Quality Assurance Specialist

    We are seeking a skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for reviewing and preparing qualification documents, handling post-implementation changes, executing OQ and PQ, and ensuring compliance with internal/external audits.

    Key Responsibilities:

  • Review and prepare MES & other GMP Software Qualification Documents
  • Prepare URS, GxP Risk Assessment, Qualification protocols (OQ, PQ), RTM, VSR
  • Review URS, RA, Design documents, qualification document
  • Handle post-implementation changes documents
  • Execute OQ and PQ
  • Prepare compliance report for internal / external audit and Compliance of internal/external audit points
  • Initiate, investigate, and evaluate Change control, CAPA, and deviation
  • Prepare and review SOPs
  • Initiate, investigate, lock, and closing of TCC, CC, Deviation, and Incident report and verify the implemented CAPA and its effectiveness
  • Prepare PQR/APR
  • Investigate and report preparation of Market Complaints and product failures at shop floor
  • Online review of GMP documents

    About Us:

    Seven-Consultancy is a leading provider of recruitment services in the medical device manufacturing industry. We pride ourselves on delivering high-quality candidates who meet the unique needs of our clients.



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