About the role
Key Responsibilities:
- Prepare and review technical documentation including:
- Master Formula Records (MFR)
- Batch Manufacturing Records (BMR)
- Product Development Reports (PDR)
- Technology Transfer Dossiers
- Analytical Method Development & Validation Reports
- Stability protocols and reports
- Master Formula Records (MFR)
- Draft, revise, and maintain SOPs related to:
- R&D operations (Formulation & Analytical)
- Documentation practices
- Equipment handling and process controls
- MHRA-compliant procedures and documentation standards
- R&D operations (Formulation & Analytical)
- Ensure all documentation is MHRA-ready, audit-compliant, and follows data integrity (ALCOA+) principles.
- Support preparation of CTD/eCTD regulatory modules, especially CMC (Module 3) sections, as per MHRA submission requirements.
- Liaise with cross-functional teams (F&D, ADL, QA, Regulatory, Manufacturing) for accurate documentation and technical data.
- Maintain document control systems, ensure version control, and manage archival of records.
- Provide documentation support during MHRA audits, mock audits, and internal quality reviews.
- Track project documentation timelines and deliverables to ensure regulatory submission readiness.
- Review and maintain change control documentation linked to formulation and analytical processes.