Technical Writer
Date: Nov 9, 2023
Location:
Toronto, Canada, Ontario, M1B2K9
Company: Teva Pharmaceuticals
Job Id: 52391
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Working independently under the supervision of the Sr. Manager, QC laboratory, the incumbent manages and coordinates activities associated with documentation testing specification, product monographs, analytical
documentation templates and testing records that support Quality Control analytical testing and release in a timely, cost effective and compliant manner. The incumbent will also set-up and manage laboratory GMP generated
documents on a validated electronic document management system.
How you’ll spend your day
Administer changes to Product Monographs, Testing Specification to meet regulatory (compendia, GMP, cGMP,
SOP) and business requirements
Create, maintain and revise testing specification and monographs to reflect latest approved/current compendia
and house methods, comment pages, and validation certificates prior to effective dates
Record and maintain an accurate history of change for all monograph updates and specification updates
Administer the associated Document Management System (active and archived documents) in a compliant and
organized manner
Assist in review of compendial updates for each compendial publication
Manage and coordinate all LIMS configuration changes to raw material, finished product, stability and packaging
component specifications
Create, maintain and revise testing specifications in LIMS to ensure accuracy of information
Manage the LIMS configuration change requests (LCCR) to ensure LIMS configuration are in line with the testing
specification and reflect the requirement at different testing stages.
Collaborate with various internal departments to ensure other relevant computer systems and databases (EDMS,
SAP) are up to date and harmonized
Create, maintain and revise LIMS Approved Supplier Table to ensure accuracy of information
Administer changes to Analytical test methods, Analytical Testing Templates/Analytical Testing Record to meet
regulatory (compendia, GMP, cGMP, SOP) and business requirements
Create of new test method and revise the existing test method, validation certificates, SOPs and general
laboratory conventions
Process the request to assign the number of the test method.
Maintain and revise Analytical Testing Templates/Analytical Testing Record to reflect latest approved or current
compendia and house methods prior to the effective date
Record and maintain an accurate history of change for all templates
Administer the associated Document Management System (active and archived documents) in a compliant and
organized manner
Assist regulatory submissions with providing required submission document by established timelines
Review submission document requirement for API, Excipients and Finished Product (as required)
Collaborate with various internal and external sources to collect information and prepare documents
Organize the collected documents and provide the required document to RA on a timely basis
Your experience and qualifications
University Degree or College Diploma in Chemistry or related science
Minimum one (1) year of experience in the related field.
Knowledge of analytical instrumentation, techniques and testing
Good computer skills with proficiency in Microsoft Office and Labware LIMS, SAP navigating online compendia
publications
Good knowledge of QA business processes & RA business processes. Good understanding of:
Analytical methods and techniques common to QC Lab
GMP, cGMP and other regulatory requirements
Key measurements to support business related to customer service
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
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