M

Junior Executive QA

Meril Vapi Taluka, Gujarat, India

Oct 14
qa Mid (2-5 yrs) Full-time India
Create a free account to apply — email only, no card. You can also save this posting or score it against your profile with AI.

About the role

Ensure compliance with USFDA, GMP, and ISO 13485 requirements while maintaining and reviewing quality documentation and records. Support CAPA, deviation, change control, and non-conformance processes, and assist with audits, regulatory inspections, and quality system activities.

What they look for

USFDA Regulations Good Manufacturing Practices ISO 13485 Quality Management Systems Quality Documentation Record Management Corrective And Preventive Action Deviation Handling Change Control Non-Conformance Management Root Cause Analysis Internal Audits Regulatory Inspections Regulatory Compliance Standard Operating Procedures Attention To Detail

Requirements

Requires 1–3 years of experience in the medical device or pharmaceutical industry and a relevant B.Pharm, M.Pharm, B.Sc., or M.Sc. qualification. Candidates should know USFDA regulations and QMS, and have experience with documentation, CAPA, deviations, root cause analysis, audit readiness, and regulatory compliance.

Full description

Job Description: Junior Executive – Quality Assurance (USFDA – MYVAL)

Experience: 1–3 years in the Medical Device/Pharmaceutical industry

Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. in a relevant discipline

Key Responsibilities:

  • Ensure compliance with USFDA, GMP, and ISO 13485 requirements.
  • Maintain and review quality documentation and records.
  • Support CAPA, deviation, change control, and non-conformance management.
  • Assist in internal audits, regulatory inspections, and quality system activities.
  • Ensure adherence to SOPs and quality standards.

Requirements

Key Skills:

  • Knowledge of USFDA regulations and Quality Management Systems (QMS).
  • Documentation and record management.
  • CAPA, deviation handling, and root cause analysis.
  • Audit readiness and regulatory compliance.
  • Attention to detail and effective communication.

Similar roles