Technical Writer - Hamilton, Canada - AtomVie Global Radiopharma Inc.

AtomVie Global Radiopharma Inc.

Verified Company

Hamilton, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

We are a community that challenges ourselves professionally, are proud of what we can accomplish together, and take pride in the impact that we can make with our clients and patients across the globe.

We can't wait for you to begin your career with AtomVie and to help us achieve our vision:
to transform lives by revolutionizing healthcare.

About the Role

Reporting to the Manufacturing Process Manager, the
Technical Writer will provide practical, technical, and operational support by authoring, editing and/or providing input on documents associated with successful manufacturing operations and will also provide support with continuous improvement projects.

This role works cross-functionally with internal departments and external resources on technical writing related issues.

What You Will Do

Write (author), revise, review, and approve technical documents, validation documents (protocols, reports), guidelines, policies, standard operating procedures (SOPs), specifications, forms, master batch records, control forms etc. according to regulatory guidelines (ICH, USP, etc.) for review by management, QA and/or customers. Assist in improving or creating templates as needed
Write (author), revise, and review quality systems documents including investigation reports, nonconformance reports, corrective and preventive action reports, root cause analysis, audit reports, gap analyses, and risk assessments.
Complete all assigned documentation in a timely fashion while ensuring consistent high quality and compliance with Good Manufacturing Practices (GMP).
Conduct research and collect all necessary information to support documents being generated.
Assist with mapping of various processes and identify nonvalue adding tasks that can be improved in order to achieve better work efficiencies
Coordinate various project related activities to ensure on time delivery of the project
Coordinate the timely completion of QMS documents and ensure department KPIs are met at all times
Initiate and present change controls in the change control committee, to implement/revise/improve programs/documents and methods and monitor completion of all work in a timely fashion. Follow up to close change controls
Initiate CAPAs as required and follow up through successful implementation and effectiveness checks.
Support, as needed, the documentation of items required for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)
Coordinate and monitor completion of documents with coworkers within the manufacturing. Act as point of contact for other departments and team members for matters related to documentation.
Assist with continuous improvement initiatives
Complete all other assigned duties, as requested.

Experience Necessary

B.Sc. in Chemistry, Biochemistry, Biotechnology, or a related discipline.

What You Bring To The Role

Has strong verbal and written communication skills.
Excellent grammar and composition.
Efficient writer; able to quickly produce wellorganized, logical, scientifically sound, comprehensive, and easytofollow documents.
Efficient writer; able to quickly produce wellorganized, logical, scientifically sound, comprehensive, and easytofollow documents.
Proficient in using various types of computer software including advanced level skills with Microsoft Word and Excel
Fast learner with an aptitude for learning and researching new innovative approaches used within the industry
Demonstrated understanding of GMP regulations.
Good time management skills.
Ability to work both independently and cooperatively in a team environment.
Flexibility in work schedule to support a 7day work week

AtomVie offers: