Executive, Technical Writing
Core
Create, maintain, and audit technical documentation (SOPs, work instructions, reports) for manufacturing and quality systems to ensure compliance with cGMP and regulatory requirements.
Role type
Senior Technical Writer (Pharmaceutical/Regulatory)
Builds
Standard operating procedures, work instructions, technical reports, and change control logs for manufacturing processes.
Domain
Pharmaceutical manufacturing and regulatory compliance
Required skills
Technical writing, cGMP compliance knowledge, document lifecycle management, regulatory audit execution, stakeholder collaboration, process documentation, change control management, quality system documentation, gap analysis, training support
Preferred skills
Master of Pharmacy (M. Pharm)
Technologies
Document control systems, change control logs
Responsibilities
Prepare and maintain technical documents in compliance with cGMP; conduct periodic document audits; collaborate with manufacturing and quality teams to translate technical info into compliant docs; review existing documentation for gaps and inconsistencies; support document control lifecycle; maintain accurate documentation records; participate in process improvement projects; support training activities related to documentation standards.
