Senior Officer QA

Posted Yesterday
Be an Early Applicant
Pardi, Valsad, Gujarat, IND
In-Office
Senior level
Hardware • Healthtech • Manufacturing
The Role
Monitors qualification and validation activities across manufacturing segments; prepares and reviews technical files, validation protocols, reports, and regulatory documentation; reviews raw data, analytical reports, batch manufacturing records, job cards, batch release certificates, and data mapping reports; and supports GMP compliance and cross-functional validation activities.
Summary Generated by Built In

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



  • Skills Required

    • 0–2 years of experience in the medical device or pharmaceutical industry
    • Qualification and validation experience, including IQ/OQ/PQ
    • Technical documentation and technical file preparation
    • Validation protocol and report preparation and review
    • Raw data review and documentation verification
    • GMP compliance and regulatory documentation experience
    • Batch Manufacturing Record and analytical report review
    • Cross-functional coordination and validation support
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    The Company
    HQ: Vapi
    8,220 Employees
    Year Founded: 2006

    What We Do

    Founded in 2006, Meril is an India-based global medical device company dedicated to innovating, designing, and manufacturing clinically relevant healthcare products. It develops vascular intervention, orthopaedic, diagnostics, endo-surgery, ENT, and robotic solutions, collaborating with physicians and global innovators to address unmet clinical needs. Through research, development, manufacturing, scientific communication, and distribution, Meril aims to alleviate human suffering and improve quality of life worldwide.

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