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Senior Officer QA

Meril Vapi Taluka, Gujarat, India

Oct 14
qa Junior (0-2 yrs) Full-time India
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About the role

Monitor qualification and validation activities across manufacturing segments, and prepare technical files and related documentation. Prepare and review qualification and validation protocols and reports, and review raw data and records including analytical reports, BMRs, job cards, batch release certificates, and data mapping reports.

What they look for

Qualification And Validation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Technical Documentation Technical File Preparation Protocol And Report Preparation Protocol And Report Review Raw Data Review Documentation Verification Good Manufacturing Practice (GMP) Compliance Regulatory Documentation Batch Manufacturing Record (BMR) Review Analytical Report Review Cross-Functional Coordination Validation Support

Requirements

The posting seeks 0–2 years of experience in the medical device or pharmaceutical industry; additional job data lists 1–3 years. Relevant capabilities include qualification and validation, technical file preparation, protocol and report review, GMP and regulatory documentation, and review of manufacturing and analytical records.

Full 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

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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