Technical Writer - qa documentation, qms, iso 13485, sops, work instructions, validation, etc.
Global Pharmaceutical Company
- Contractor with knowledge or experience in Procedure and Technical writing :
Length of assignment and start date : Long term thru end of 2022
Is Tru a must ? TruVault or VeevaVault is nice to have
- Support Data governance and master data teams by writing the procedures (SOPs & Wis) and
- Gaining alignment & approvals. Should be knowledgeable in procedure writing and in the tru document management system
Full Job Description
-Bachelor’s degree or equivalent work experience
-Experience in the pharmaceutical, biotech, or medical device sector
-Minimum of 5+ years of technical writing experience
-Experience in using a Document Management System(s) as a Technical Writer
-Familiarity with SAP/ ERP type system(s)
-Proficient with configuration change management principles and working knowledge of following and tracking record retention schedules.
-Must have experience with CAPA and CAPA responses
-Knowledge of ISO 13485, FDA QSRs and GMP
-Strong communication skills
-Extensive knowledge of Tru, Trulogic, truedit, trackwise
This candidate will work closely with cross functional site teams to write, edit, review and finalize technical documents. The individual will write or process, and implement Quality Records. Update master documents to reflect approved changes; update master indexes and update files to supersede older revisions, as needed.
-Initial onboarding of the sites policies and procedures for understanding of the Quality System and processes at the site
-Under the direction the project manager (PM), assigned tasks to review, edit, and comment on technical documentation. Issue weekly progress to plan reports as requested by PM
-Review technical literatures and published materials and recommends revisions or changes in scope, format, and content.
-Maintain records and files of work and revisions
-Technically strong to work independently with R&D and various scientists to create and transfer
technical information into finished documentation that include but not limited to CAPA records, Device masters, Training records, etc.
-Lead cross functional documentation projects as requested and under the direction of the PM
-Standardize and streamlines documents and documentation process in coordination with chemists and managers