Sop Writer

An SOP (Standard Operating Procedure) document writer from an API (Active Pharmaceutical Ingredient) manufacturing industry plays a critical role in ensuring compliance with regulatory standards and facilitating consistent operational practices.

 Here are the key deliverables:

1. Development and Documentation

• Write clear, precise, and comprehensive SOPs for various processes, equipment, and systems in the manufacturing facility.
• Ensure SOPs are consistent with regulatory requirements such as Good Manufacturing Practices (GMP) outlined by international authorities (e.g., MHRA &, USFDA)
• Collaborate with subject matter experts (SMEs), including process engineers, quality assurance (QA) personnel, and production staff, to gather accurate information.

2. Regulatory Compliance

• Ensure SOPs meet the standards of local and international regulatory bodies.
• Incorporate requirements of quality guidelines like ICH Q7 for API manufacturing.
• Regularly update SOPs to reflect changes in regulations, technologies, or processes.

3. Review and Approval

• Work closely with QA/QC (Quality Control) teams for reviewing and finalizing SOPs.
• Coordinate with relevant department heads and regulatory teams for approval processes.
• Maintain an SOP review schedule to ensure documents remain current and valid.

4. Training and Implementation Support

• Assist in training employees on new or revised SOPs to ensure proper understanding and adherence.
• Create training materials or guides based on SOP content.
• Monitor the implementation of SOPs to identify any gaps or need for clarification.

5. Version Control and Documentation Management

• Maintain a robust system for version control of SOPs.
• Archive obsolete SOPs as per document retention policies.
• Ensure easy accessibility and proper categorization of documents in the document management system (DMS).
• Participate in audits (internal or external) to address SOP-related observations and findings.

7. Coordination with Departments

• Liaise with manufacturing, R&D, QA, QC, and other departments for comprehensive SOP creation.
• Incorporate inputs on safety, quality, and environmental practices.

8. Audit Readiness

• Ensure all SOPs are audit-ready, properly formatted, and in compliance with regulatory guidelines.
• Address any gaps or inconsistencies identified during audits or inspections.

Skills and Qualifications

• Strong understanding of API manufacturing processes.
• Knowledge of regulatory requirements like GMP, WHO, and ICH guidelines.
• Excellent technical writing skills.
• Familiarity with document management software and systems.

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