Lead Executive - Site Support

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

• Education
  • Bachelor s/ Master s degree in Science / Pharmacy
• Knowledge, Skills and Abilities
  • Strong verbal and written English communication skills.
  • Excellent organization and writing skills
  • Understanding of GMPs, SODs.
  • Strong presentation skills to facilitate communication of initiatives in various forums - small group presentations, large employee meetings and briefings with senior leadership
  • Proven strong organizational, time management, and project management skills. Demonstrated experience in coordinating project activities
  • Strong knowledge of GMP
  • Proficiency with Word, Excel, Powerpoint, and Project Management.
• Experience
  • Minimum of eight years relevant working experience in the pharmaceutical industry.

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