Documentation Engineer

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