Lead Exec, Site Support

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.

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Job Summary

Responsible for processing and managing changes required to Master Production and Packaging documentation; maintaining the Document management and SOD system for Apotex .

Job Responsibilities

• Provide coaching assistance and ongoing support to Change Owners on requirements for completing Change Control packages.
• Responsible for creating and / or making formatting changes and edits to draft master documents.
• Serve as a technical resource in the development of Master Production & Packaging documentation by advising on current Document Naming Conventions Active Standard Instruction requirements & Master Template issues.
• Conduct Detailed Impact Analysis for Master Production Documents according to proposed change details.
• Perform functions related posting and publishing approved documents.
• Responsible for initiating change control packages in the change management system with detailed change(s) descriptions and the corresponding rationale(s) for Manufacturing Packaging POMSNET recipes SODs and supporting SAP information.
• Review the accuracy of all manufacturing instructions imported into master documents during detailed Impact Analysis as listed in the scope of the change request.
• Track and follow up the progress of change control requests to meet committed business timelines.
• Using the LEAN tools and methodology work as a change agent to drive and facilitate positive change - continuous improvement.
• Lead facilitate and / or support the development of project design justification and scope in collaboration with process owners and other key stakeholders.
• Develop and revise Standard Operating Documents governing and relating to Manufacturing Support functions as required.
• Organize and implement all SOD change requests to defined deadlines.
• Complete detailed impact analysis on SOD change requests.
• Provide expertise to customers on the development of Site SODs.
• Manage the document approval process using Content Server and QMS trackwise.
• Demonstrate Behaviours that exhibit our organizational Values : Integrity Teamwork Courage and Innovation.
• 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.

Job Requirements

Bachelors / Masters degree in Science / Pharmacy

Strong verbal and written English communication skills.

At Apotex we are committed to fostering a welcoming and accessible 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.

Key Skills

Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

Employment Type : Full Time

Experience : years

Vacancy : 1