Job Description
The Technical Writer position is responsible for writing methods, protocols, reports, SOPs and evaluating compendia procedures as it impacts the pharmaceutical products or raw materials.
- Manage medium and larger size projects and in collaboration with client and internal resources.
- Work with department manager and schedule projects according to projects prioritization and work with groups and functions to manage resources efficiently.
- Leading technical writer team for improvement initiatives and workload distribution.
- 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.
- In addition, 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.
- Working with chemistry laboratory personnel, write or review reports for method development, feasibility, transfer verification and validation projects.
- Working with chemistry laboratory personnel, write or review client methods for routine sample analysis as needed.
- Review various lab documents.
- Ensure timely review of compendia updates, such as USP, EP, JP.
- Document and communicate the compendia changes to impacted departments
Qualifications
Bachelor’s or master’s degree in Chemistry or a related science degree and two or more years related pharmaceutical experience.Experience minimum : 2 to 3 years experience in a Pharmaceutical LabMust be able to communicate clearly in English and have solid communication skills including grammar and composition.Have excellent interpersonal skills.Ability to work well with others & independently.Proven time management skills and a strong attention to detail.Knowledge of another language is an asset.Demonstrated understanding of cGMP regulations.