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harikrushna machines pvt. ltd.

Documentation Engineer

harikrushna machines pvt. ltd.
Ahmedabad, India
2-5 Years
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Job Description

Location: Ahmedabad

Experience: 2-5 Years

Job Responsibilities :

  • Prepare and maintain validation documents:
    • FAT (Factory Acceptance Test)
    • DQ (Design Qualification)
    • IQ (Installation Qualification)
    • OQ (Operational Qualification)
    • PQ (Performance Qualification)
  • Prepare SOPs, protocols, reports, checklists, manuals, and GMP documents.
  • Handle document control, revision, and record maintenance.
  • Coordinate with Design, Production, QA, and Automation departments.
  • Support FAT/SAT activities and customer audits.
  • Ensure compliance with GMP, cGMP, FDA, and GAMP guidelines.
Required Skills

  • Knowledge of pharmaceutical machine validation documentation.
  • Good understanding of FAT, DQ, IQ, OQ, and GMP documentation.
  • Strong MS Office and technical writing skills.
  • Good communication and coordination abilities.

Preferred Industry

  • Pharmaceutical Machinery / Pharma Equipment Manufacturing

Job Responsibilities :

  • Prepare and maintain validation documents:
    • FAT (Factory Acceptance Test)
    • DQ (Design Qualification)
    • IQ (Installation Qualification)
    • OQ (Operational Qualification)
    • PQ (Performance Qualification)
  • Prepare SOPs, protocols, reports, checklists, manuals, and GMP documents.
  • Handle document control, revision, and record maintenance.
  • Coordinate with Design, Production, QA, and Automation departments.
  • Support FAT/SAT activities and customer audits.
  • Ensure compliance with GMP, cGMP, FDA, and GAMP guidelines.
Required Skills

  • Knowledge of pharmaceutical machine validation documentation.
  • Good understanding of FAT, DQ, IQ, OQ, and GMP documentation.
  • Strong MS Office and technical writing skills.
  • Good communication and coordination abilities.

Preferred Industry

  • Pharmaceutical Machinery / Pharma Equipment Manufacturing

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceutical Machinery
Employment Type:
Full time

Job ID: 147501347

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Last Updated: 15-05-2026 11:49:22 PM
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