Apotex Inc.
Website:
apotex.com
Job details:
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .
Job Summary
- Responsible for creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) for Apotex.
- Responsible to escalate any critical issues arising from the MMaR / MPaR while
- Responsible for working on POMS
- Responsible to Support Manufacturing Execution System
- Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
Job Responsibilities
- Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports).
- Migration of MPPDs into new MMaR & MPaR
- Working on MMaR execution in POMS
- Working with Vendor and GTA to Support Manufacturing Execution System project in Design, Configuration and Master Data processes.
- Execution and Cancellation of documents in Content
- Creation and peer review of MDoc’s for Cancellation CCR’s.
- Drafting and review of MMaRs and MPaRs for Richmond Hill
- Responsible for Primary Technical Writer role for change control process for cancellation of documents for Signet and Etobicoke sites.
- Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site.
- Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
- Manage own workload and completion of assigned MMaR & MPaR within established cycle time
- Perform all work in compliance with current SODs and
- Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the Team leader.
- Develop and maintain effective working relationships with internal and external
- Works as a member of a team to achieve all
- Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety
- Works in a safe manner collaborating as a team member to achieve all
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements - Education
- Bachelor’s/ Master’s degree in Science / Pharmacy
- Knowledge, Skills and Abilities:
- Should be proficient in MS office tools.
- Should have excellent verbal & written communication skills.
- Experience of working on online modules / software would be an added advantage.
- Working knowledge of a document management system required.
- Ability to be flexible and multi-task in a rapidly changing environment.
- Experience
- Minimum 2-4 year of experience in the Pharmaceutical industry.
At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Click on Apply to know more.
