FSP-Scientific/Technical Writer
Core
Create, review, and maintain GMP/GLP documentation (SOPs, batch records, risk assessments) to support sterile manufacturing operations and ensure data integrity.
Role type
Sterile Manufacturing Scientific/Technical Writer
Builds
GMP-compliant documentation systems for sterile parenteral product development and clinical needs
Domain
Pharmaceutical manufacturing / Sterile operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, SOP development, batch record management, risk assessment, data integrity principles, aseptic manufacturing knowledge, process improvement, problem analysis, scheduling and planning, technical writing, Microsoft Office proficiency
Preferred skills
GMP manufacturing experience, understanding of Global Quality Policies
Technologies
Microsoft Word, Microsoft Outlook
Responsibilities
Ensure compliance with cGMPs and GSK standards for sterile manufacturing documentation; Prepare and oversee GMP/GLP documents including SOPs, production forms, and batch records; Generate and report metrics for sterile operations processes; Inspect work areas for safety regulations and recommend improvements; Provide technical support as a Subject Matter Expert on GQP topics; Apply continuous improvement activities to enhance process quality and efficiency; Schedule and plan work to meet business priorities; Perform administrative tasks such as procedure revision and records archiving.
Seniority
Mid-level, hands-on IC
