Executive, Manufacturing Documentation - Site Support

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 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 new 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.
• Responsible for Primary Technical Writer role for change control process in creation of MMaR and MPaR 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 requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• 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 3-4 years of experience in the Pharmaceutical industry.