Technical Writer II (H&N Pharma - R&D)

Job Description

Primary Responsibilities

• Writing methods, protocols, reports, SOPs and evaluating compendia procedures as it impacts the pharmaceutical products or raw materials.
• Responsible for supporting the scientists in R&D to prepare the documentation as required by clients, including follow up of change controls, maintaining the templates for laboratory documents.
• Responsible for periodic review of the compendia changes and providing evaluation as it impacts the Raw Material, Finished Product and R&D groups within Analytical Operations.

Specific Responsibilities

• Write or review protocols for method development, feasibility, transfer, verification, and validation projects in collaboration with R&D personnel. Write or review client methods for routine sample analysis as needed.
• Collect and provide the necessary documentation for R&D projects, such as sample specifications, method details, and validation reports. Ensure the testing instructions are timely available and unambiguous, to facilitate the bench work complete as scheduled.
• Document analytical findings by compiling data into standardized report templates.
• Review the compendia updates (e.g., USP, EP, JP), document changes, and communicate updates to relevant departments. Act as a technical resource for team members, providing guidance on documentation issues.
• Track the progress of R&D projects to ensure completion, including document organization. Inform the appropriate manager if assigned work cannot be completed within the expected timeframe and quality standards.
• At all times, comply with SGS Code of Integrity and Professional Conduct and with all SGS QHSE and HR policies and procedures. Ensure the work area in GBS is always clean and presentable.

Qualifications

• Bachelor's degree in chemistry or a related science field, with 3-5-year experience, or master's degree in chemistry or a related science field, with minimum 2 years of experience, in pharma laboratory setting, preferably in R&D.
• Good understanding of analytical methods, the ability to break down complex procedures into detailed steps, and familiarity with planning and documenting new method development.
• Demonstrated understanding of cGMP regulations. Knowledgeable in all regulatory guides impacting their specialized field, such as ICH, FDA, TPP, pharmacopeias.

Additional Information

• Excellent command of the English language (C1 as minimum), with strong verbal- and written communication skills (grammar and composition).
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
• Proven ability to manage and coordinate multiple projects in a fast-paced, professional environment.
• Strong interpersonal skills and the ability to work both collaboratively and independently.
• Proven time management skills and meticulous attention to detail.