Assistant Manager - Site Support

Job Summary

Responsible for operation supports of Manufacturing Execution Systems (MES) and Document Management Systems (DMS) for Apotex Signet and Etobicoke, such as SAP PP, SAP DMS, POMSnet, and Content Server (MPPD module).

Job Responsibilities

• Expert knowledge of each, and the interfacing of, Manufacturing Execution Systems (MES) and Document Management Systems (DMS) for Apotex Signet and Etobicoke sites. MES/DMS systems include but not limited to: SAP PP, SAP DMS, SAP ATTP, POMSnet, Content Server, QMS Trackwise, and MS Word/Excel Templates.

• Conduct Detailed Impact Analysis to proposed product and/or MES/DMS system changes, with scope that span multiple department/operations. Detailed Impact Analysis includes but is not limited to the following:
  • Assess MES/DMS structure and state
  • Identify compliance requirements within the process of the MES/DMS
  • Assess and update relevant SOD references
  • Impact of change on overall Products and Production/Packaging operations

• Act as change owner/SME, implement MES/DMS related computer system changes
  • Develop systems solutions in conjunction with GIS/internal stakeholders
  • Plan, write and execute Test Cases as required in support of corrective or improvement initiatives
  • Create/update templates/standards as required in support of corrective or improvement initiatives
  • Maintain SAP transactions for automated Master document issuance
  • Troubleshoot system issues with and providing coaching to internal/external stakeholders

• Act as Super User for one or more MES/DMS systems. Serve as a technical resource to internal/external customers and key stakeholders in the for MES/DMS systems.
  • Responsible for day-to-day troubleshooting of operation issues in areas such as Production and Packaging. Support, coach and mentor internal customers as required
  • Perform custom queries and/or MES/DMS system investigations to provide information to internal/external stakeholders
  • Deliver training and/or creating training materials on technical topics
  • Review opportunities for continuous improvement of MES & DMS applications and enhancements for business processes

• Act as Role Owner for MES & DMS systems of high complexity
  • Support internal/external customers with role owner specific access and expert knowledge
  • Ensure all training materials are updated and kept current
  • Approve training requests, and coordinate training sessions enterprise wide, address training/access issues
  • Participate in complex systems investiagation/projects that involves multi-site, multi-department, multi-system interfaces and large user base. Propose solutions and lead implementation of computer system changes.
  • Identify, in conjunction with the management team, reports and enhancements, which can improve the operations of MES & DMS to contribute to business initiatives

• Complete assignments with strict deadlines and within established cycle time commitments under minimal supervision. Able to prioritize workload to deliver as per business needs.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, teamwork, 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.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor’s/ master’s degree in science / pharmacy or post-secondary education required, University degree in related discipline preferred
• Knowledge, Skills and Abilities
  • Understanding of GMPs, SODs
  • Good organization skills and report writing skills
  • Proficient in working with MS Office Suite (Microsoft Word, Excel)
  • Understand the business process within Production and Packaging areas
  • Working knowledge of MES/DMS systems; knowledge of multiple systems, and/or advance knowledge preferred.
  • Working knowledge of system and data change control procedures
  • Strong data analysis skills
  • Ability to strategically investigate problems independently, determine root cause and propose solutions
  • Demonstrated knowledge of organizational structure and functions across Apotex and affiliates
  • Ability to be flexible and multi-task in a rapidly changing environment
  • Ability to complete and coordinate projects with strict deadlines
  • Well developed interpersonal and team work skills
  • Strong verbal and written English communication skills
  • Effective coaching and training skills
• Experience
  • Minimum of 8 years relevant working experience in the pharmaceutical industry.
  • Previous Production/Packaging/Documentation experience in the pharmaceutical industry is an asset
  • Experience in and proficient use of Microsoft Office software, in network environment
  • SAP, POMSnet, and Content Server experience are an asset
  • Data analysis experiences an asset