Senior Officer QA

Meril; Valsad District; On-site; INR 360,000 - 600,000; Full time

Job summary

Meril in India seeks a QA/Validation professional with 0-2 years of experience in Medical Device/Pharma to assist qualification, validation and documentation activities. You will prepare technical files, protocols and reports, and review data and batch records to ensure quality and regulatory compliance.

You will collaborate with cross-functional teams across manufacturing segments, supporting validation efforts and maintaining GMP standards in a fast-paced environment.

Qualifications

• IQ/OQ/PQ qualification & validation experience required.
• Technical documentation and technical file preparation.
• Protocol and report preparation and review.
• Data review and documentation verification.
• GMP compliance and regulatory documentation understanding.
• BMR and analytical report review.
• Cross-functional coordination and validation support.

Responsibilities

• Monitoring 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.
• Support validation activities across multiple manufacturing segments.

Skills

IQ/OQ/PQ

Technical Documentation

Protocol & Report Preparation

Data Review

GMP Compliance

BMR & Analytical Review

Cross-functional Coordination

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

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