Executive Manufacturing Doentation - Site Support

About the job

About Apotex Inc.

Apotex Inc. is a Canadianbased global health company that produces highquality affordable medicines for patients around the world. Apotex employs almost 7200 people worldwide in manufacturing RD and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration the Apotex group is focused on the development and sale of generic biosimilar and specialty products.

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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.
• 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
• Bachelors/ Masters 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 multitask in a rapidly changing environment.

Experience

Minimum 34 years of experience in the Pharmaceutical industry.

At Apotex we are committed to fostering an inclusive accessible work environment where all employees feel valued respected and supported.

Apotex offers 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.

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Remote Work :

No