Senior Officer QA

Meril

Valsad District

On-site

INR 350,000 - 520,000

Full time

29 hours ago
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Job summary

Meril in India (Gujarat) seeks a Quality & Validation Associate with 0-2 years of experience in the Medical Device/Pharma sector to monitor qualification and validation activities and support multiple manufacturing segments across the site in Gujarat.

The role includes preparing and reviewing technical files, protocols, and reports, reviewing raw data and analytical reports, and ensuring GMP-compliant documentation across projects.

Qualifications

  • IQ/OQ/PQ experience in qualification and validation.
  • Technical documentation and technical file preparation.
  • Protocol and report preparation and review.
  • Data review and documentation verification.
  • GMP compliance and regulatory documentation.
  • BMR & analytical report review.

Responsibilities

  • Monitoring of qualification and validation activities.
  • Preparation of technical files and related documentation.
  • Preparation and review of qualification & validation protocols and reports.
  • Review of raw data, including analytical reports, BMRs, job cards, batch release certificates, data mapping reports, etc.
  • Support validation activities across multiple manufacturing segments

Skills

Cross-functional coordination
Documentation handling

Tools

IQ/OQ/PQ

Job description

0-2 year experience in Medical Device/Pharma industry.

Job Responsibility
  • Monitoring of qualification and validation activities.
  • Preparation of technical files and related documentation.
  • Preparation and review of qualification & validation protocols and reports.
  • Review of raw data, including analytical reports, BMRs, job cards, batch release certificates, data mapping reports, etc.
  • Support validation activities across multiple manufacturing segments

0-2 year experience in Medical Device/Pharma industry.

Job Responsibility
  • Monitoring of qualification and validation activities.
  • Preparation of technical files and related documentation.
  • Preparation and review of qualification & validation protocols and reports.
  • Review of raw data, including analytical reports, BMRs, job cards, batch release certificates, data mapping reports, etc.
  • Support validation activities across multiple manufacturing segments
Requirements
  • Qualification & Validation (IQ/OQ/PQ)
  • Technical Documentation & Technical File Preparation
  • Protocol and Report Preparation & Review
  • Data Review & Documentation Verification
  • GMP Compliance & Regulatory Documentation
  • Batch Manufacturing Records (BMR) & Analytical Report Review
  • Cross-functional Coordination & Validation Support
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