job title: Trainee site support(apotex)

Roles and Responsibilities

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 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.

• Creation and peer review of MDoc’s for Cancellation CCR’s.

• 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.

• Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.

• 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 0-1 years of experience in the Pharmaceutical industry.