Deskripsi Pekerjaan
Join our dynamic team as a Technical Writer specializing in pharmaceutical laboratory documentation. You will play a crucial role in translating complex scientific procedures into clear, compliant documentation that drives regulatory compliance and operational excellence. This position offers the opportunity to work directly with R&D and quality teams to develop critical documents that ensure product safety and efficacy. Your expertise will directly impact pharmaceutical manufacturing standards and regulatory approvals. Ideal for detail-oriented professionals seeking to advance their career in scientific documentation within a fast-paced, regulated environment.
Tanggung Jawab
- Develop and maintain comprehensive technical documentation including SOPs, methods, protocols, and regulatory reports
- Evaluate compendia procedures to ensure alignment with pharmaceutical quality standards
- Collaborate with scientists and quality assurance teams to document laboratory processes
- Ensure all documentation adheres to GMP/GLP guidelines and regulatory requirements
- Revise existing documentation to incorporate process improvements and regulatory updates
- Manage document control systems including versioning and distribution
- Prepare documentation for regulatory submissions and audits
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field
- Minimum 2 years technical writing experience in pharmaceutical/biotech industry
- Proficiency in regulatory documentation standards (GMP, GLP, ICH guidelines)
- Strong knowledge of pharmaceutical laboratory processes and compendia procedures
- Exceptional attention to detail and precision in documentation
- Advanced proficiency in Microsoft Office and documentation tools
- Excellent written communication skills with ability to simplify complex technical concepts
- Experience with document management systems preferred