QA Equipment Validation

Maya Biotech

Solan

On-site

INR 900,000 - 1,500,000

Full time

4 days ago
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Job summary

Maya Biotech is seeking a Sr. Executive QA Equipment Validation to manage and review equipment qualification activities in a GMP-driven environment in India.

You will ensure adherence to regulatory requirements and quality standards, coordinating across engineering, production, QC and QA teams while maintaining robust validation records. Responsibilities include drafting validation plans, reviewing protocols, and supporting audits/inspections to ensure timely closure of qualification activities

Qualifications

  • Experience in pharmaceutical manufacturing and GMP environments.
  • Hands-on IQ/OQ/PQ execution and risk assessments.
  • Strong documentation and report-writing skills.

Responsibilities

  • Execute/review DQ, IQ, OQ and PQ activities for equipment.
  • Prepare and review URS, validation protocols, qualification reports.
  • Ensure qualification activities follow approved protocols and timelines.
  • Review equipment specs, drawings, calibration and maintenance records.
  • Coordinate with Engineering, Production, QC, QA and vendors.
  • Review deviations, discrepancies, CAPA and change controls.
  • Ensure GMP and data integrity in validation activities.
  • Support periodic review, requalification and lifecycle management.
  • Participate in audits/inspections and provide validation docs.
  • Maintain validation trackers and timely closure of activities.

Skills

Equipment qualification
Validation lifecycle
GMP compliance
IQ/OQ/PQ
Deviation CAPA change control
Documentation

Job description

We are looking for a Sr. Executive QA Equipment Validation to manage and review equipment qualification and validation activities in compliance with cGMP, regulatory requirements, SOPs, and quality standards.

Key Responsibilities
  • Execute/review DQ, IQ, OQ and PQ activities for pharmaceutical manufacturing and laboratory equipment.
  • Prepare and review URS, validation protocols, qualification reports, risk assessments and related documents.
  • Ensure equipment qualification activities are performed as per approved protocols and timelines.
  • Review equipment specifications, drawings, manuals, calibration and maintenance records.
  • Coordinate with Engineering, Production, QC, QA and vendors for qualification activities.
  • Review and manage deviations, discrepancies, CAPA and change controls related to validation.
  • Ensure proper documentation and compliance with GMP, data integrity and validation requirements.
  • Support periodic review, requalification and validation lifecycle management.
  • Participate in internal, customer and regulatory audits/inspections and provide validation-related documentation.
  • Maintain validation trackers and ensure timely closure of qualification activities.
Required Skills
  • Good knowledge of equipment qualification, validation lifecycle and GMP requirements.
  • Hands‑on experience with IQ/OQ/PQ, risk assessment, deviation, CAPA and change control.
  • Strong documentation and report‑writing skills.
  • Good coordination and communication skills with cross‑functional teams.
  • Experience in a pharmaceutical manufacturing environment is preferred.
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