GBS H&N Pharma - R&D Technical Writer (Level II) SGS Bogota, D.C., Capital District, Colombia 1 day ago - Be among the first 25 applicants Job Description Primary Responsibilities As a member of our Global Business Solutions (GBS) center, the Technical Writer will be responsible for writing methods, protocols, reports, SOPs, and evaluating compendia procedures as they relate to pharmaceutical products or raw materials. Additionally, they will support R&D scientists in preparing necessary documentation, including follow-up on change controls and maintaining laboratory document templates. They will also review compendia changes periodically and assess their impact on Raw Material, Finished Product, and R&D groups within Analytical Operations. Specific Responsibilities Write or review protocols for method development, transfer, verification, and validation projects in collaboration with R&D personnel, including client methods for routine analysis. Gather and provide documentation for R&D projects, such as specifications, method details, and validation reports, ensuring clarity and timeliness. Compile analytical data into standardized report templates. Review updates to pharmacopoeias (USP, EP, JP), document changes, and communicate these to relevant teams. Serve as a technical resource for documentation issues. Monitor R&D project progress, organize documents, and notify managers if deadlines or quality standards are at risk. Adhere to SGS's Code of Integrity, QHSE, and HR policies, maintaining a clean and professional work environment. Requirements Profile Bachelor’s degree in chemistry or a related science with 3-5 years of experience, or a master’s degree with at least 2 years in a pharmaceutical laboratory, preferably R&D. Strong understanding of analytical methods, ability to detail complex procedures, and familiarity with new method development documentation. Knowledge of cGMP regulations and related regulatory guides (ICH, FDA, pharmacopeias). Skills Excellent command of English (minimum C1), with strong communication skills. Proficiency in Microsoft Office Suite. Ability to manage multiple projects efficiently. Strong interpersonal skills, capable of working independently and collaboratively. Attention to detail and effective time management. Additional Information Work schedule: Monday to Friday, onsite. Salary: COP 6,000,000. Contract initially as a project-based agreement, transitioning to indefinite after 6 months based on performance. #J-18808-Ljbffr