QA/QC Executive

7 days ago


Surat, Gujarat, India Adler Talent Solutions Full time ₹ 2,00,000 - ₹ 6,00,000 per year

Role & responsibilities

To ensure that all processes, products, and systems meet the required quality standards by

implementing and monitoring the Quality Management System (QMS) in compliance with ISO

13485, GMP, and IVD regulatory requirements.

  1. Implement, monitor, and maintain the Quality Management System (QMS) in line with

    ISO 13485 and other applicable standards.
  2. Prepare, review, and manage SOPs, quality manuals, work instructions, and controlled

    documents.
  3. Review and approve batch production records, validation protocols, and quality reports.
  4. Conduct and coordinate internal audits, supplier audits, and process audits; ensure

    closure of deviations, CAPA, and NCRs.
  5. Manage change control, deviation control, and risk management activities.
  6. Coordinate management review meetings and maintain related records.
  7. Ensure training and competency assessment of staff on quality standards and GMP.
  8. Provide support during regulatory audits and inspections.

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