Engineering Documentation Specialist

Alchemie Finechem; Bharuch District; On-site; INR 500,000 - 750,000; Full time

Job summary

Alchemie Finechem in India seeks a Documentation Specialist to manage QMS/EMS documentation, maintain SOP revisions, and support internal audits. You will ensure cGMP compliance and prepare validation records (IQ/OQ/PQ) for plant equipment and processes.

The role requires organizing documents on the company server, collaborating with engineers and QA, and training new staff on documentation standards and procedures to sustain regulatory readiness.

Qualifications

• Experience with QMS/EMS documentation and SOP control.
• Familiarity with cGMP and validation protocols (IQ/OQ/PQ).
• Ability to coordinate audits and CAPA documentation.

Responsibilities

• Maintain QMS/EMS documentation and SOP revisions.
• Ensure compliance with regulatory standards (cGMP) and prepare validation records (IQ/OQ/PQ).
• Manage document control and archiving on the company server.
• Collaborate with engineers, QA and PMs to translate technical details into clear docs.
• Support audits and management reviews.
• Process change requests for documents.
• Train staff on documentation standards and procedures.
• Prepare user manuals, specs, drawings and process guides.

Skills

Documentation software

Office suites

Tools

Microsoft Word

Excel

PDF creation tools

Job description

Role & responsibilities

• ISO Compliance: Maintaining QMS/EMS standards, managing SOP revisions, and ensuring all internal audit documentation is current.
• FSSAI Regulatory Work: Ensuring strict adherence to food safety standards, maintaining central licensing documentation, and managing periodic returns/compliance reports.
• Create and edit documents: Develop and update technical documentation, including user manuals, technical specifications, drawings, and process guides.
• Manage document control: Implement and maintain a robust system for version control, revision tracking, and document archiving to ensure accuracy and prevent the use of outdated information.
• Collaborate with teams: Work closely with engineers, project managers, and other stakeholders to gather technical information and translate complex details into clear, user-friendly documentation.
• Ensure compliance: Ensure all documentation meets internal policies and relevant industry standards and regulations.
• Maintain organization: Systematically organize and store all project-related files, sketches, and drawings on the company server, ensuring a high level of organization.
• Support audits: Provide necessary documentation support during internal audits, certification audits, and management reviews.
• Process change requests: Manage and process requests for document changes and updates.
• Documentation control: Create, update, and manage a wide range of technical documentation, including Standard Operating Procedures (SOPs), user requirement specifications (URS), design specifications, and other engineering-related documents.
• GMP/regulatory compliance: Ensure all documentation adheres to pharmaceutical industry regulations, such as Current Good Manufacturing Practices (cGMP), and supports quality assurance standards. Experience with validation protocols like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) is essential.
• 5S implementation: Apply and enforce the 5S methodology (Sort, Set in Order, Shine, Standardize, Sustain) across engineering and production areas to improve efficiency, organization, and safety.
• Equipment and system management: Maintain and organize documentation for all plant equipment and utility systems, including AHUs, reactors, and pumps.
• Audit support: Provide necessary documentation and support during internal and external audits and inspections.
• Interdepartmental collaboration: Work closely with cross-functional teams, including production, quality assurance, and project management, to ensure all technical documentation is accurate and complete.
• Project support: Assist with the documentation related to the installation and commissioning of new equipment and the modification of existing facilities.
• Deviation and CAPA support: Help in documenting investigations related to deviations and implementing Corrective and Preventive Actions (CAPA).
• Training: Support the training of new employees on documentation standards and procedures.

Preferred candidate profile

Proficiency with documentation software and common office suites (e.g., Microsoft Word, Excel, PDF creation tools)