Full-Time GBS Business Support - Technical Writer II

Primary Responsibilities

• Writing methods, protocols, reports, SOPs and evaluating compendia procedures impacting pharmaceutical products or raw materials.
• Supporting scientists in R&D to prepare documentation as required by clients, including change control follow-up and maintaining laboratory document templates.
• Periodically reviewing compendia changes and evaluating their impact on Raw Material, Finished Product, and R&D groups within Analytical Operations.

Specific Responsibilities

• Writing or reviewing protocols for method development, feasibility, transfer, verification, and validation projects with R&D personnel.
• Writing or reviewing client methods for routine sample analysis as needed.
• Collecting and providing necessary documentation for R&D projects (e.g., sample specifications, method details, validation reports).
• Ensuring timely availability and unambiguous testing instructions to facilitate scheduled bench work.
• Documenting analytical findings by compiling data into standardized report templates.
• Reviewing compendia updates (e.g., USP, EP, JP), documenting changes, and communicating updates to relevant departments.
• Acting as a technical resource for team members, providing guidance on documentation.
• Tracking the progress of R&D projects, ensuring completion and document organization.
• Informing the appropriate manager if assigned work cannot be completed within timeframe and quality standards.
• Complying with SGS Code of Integrity and Professional Conduct, and SGS QHSE and HR policies.
• Maintaining a clean and presentable work area.

Qualifications

• Bachelor's degree in chemistry or related science field with 3-5 years experience, or Master's degree with minimum 2 years experience in a pharma laboratory setting, preferably in R&D.
• Strong understanding of analytical methods and the ability to break down complex procedures.
• Familiarity with planning and documenting new method development.
• Demonstrated understanding of cGMP regulations.
• Knowledgeable in regulatory guides (e.g., ICH, FDA, TPP, pharmacopeias).
• Excellent English language skills (C1 minimum).
• Strong verbal and written communication skills (grammar and composition).
• Proficiency in Microsoft Office Suite.
• Proven ability to manage and coordinate multiple projects.
• Strong interpersonal skills, ability to work collaboratively and independently.
• Proven time management skills and meticulous attention to detail.

What is the last date for applying to the job?

Which countries are accepted for this remote job?