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 for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
- Responsible to escalate any critical issues arising from the MMaR / MPaR while drafting.
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 recent MMaR MPaR templates.
- Manage own workload and completion of assigned MMaR MPaR within established cycle time commitments.
- Execution and Cancellation of documents in Content Server.
- Creation and peer review of MDocs for Cancellation CCRs.
- Drafting and review of MMaRs and MPaRs for Richmond Hill Site.
- 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.
- Perform all work in compliance with current SODs and GMPs.
- 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 customers.
- Works as a member of a team to achieve all outcomes.
- 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 re
📌 Trainee - Site Support (Mumbai)
🏢 Apotex
📍 Mumbai