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Sr. Analyst, Quality and R&D Applications
Sr. Analyst, Quality and R&D ApplicationsAPOTEX • California, MO, US
Sr. Analyst, Quality and R&D Applications

Sr. Analyst, Quality and R&D Applications

APOTEX • California, MO, US
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Sr. Analyst, Quality and R&D Applications

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.

Plan, design, develop, implement and maintain Quality and R&D Applications and related integration for enterprise solutions which meet tactical and strategic business requirements. Provide expert insight into related application and infrastructure activities to meet customers' needs.

Job Responsibilities

  • Investigate, diagnose and resolve incidents with customers and peers utilizing advanced problem-solving techniques to identify root causes
  • Ensures work is performed in compliance with the GIS Incident Management process and GIS Change Management process
  • E2E change management for patch deployments, systems enhancements, hotfixes and emergency change controls
  • Perform / Execute Installation Qualification, Configuration Verification, Functional testing and helping the users to perform User Acceptance testing.
  • Proactively advises clients on developments in relevant information technology.
  • In conjunction with customers, develops new and / or improved information systems that meet customers' functional needs and improve their business processes.
  • Responds to more complex and / or unconventional queries from managers, team members, other employees, and internal customers. Provide policy interpretation and technical / business process advice in their area of technical information technology expertise.
  • Plans, implements and oversees small information technology projects, including small portions of corporate wide information systems.
  • Utilizes often highly analytical techniques in the performance of functional duties, and to identify process inefficiencies and root causes of issues with managers, suppliers, contractors, or other external stakeholders to determine action.
  • Provide accurate and complete documentation of processes and procedures to ensure that systems can be supported.
  • Understand and communicate department objectives, translating them into project team and individual performance goals.
  • Support GIS Management during audits from internal or external customers.
  • Work with GIS peers and cross functional teams in the evaluation, implementation, enhancement, and support of solutions.
  • Perform other related duties as assigned, in accordance with job responsibilities and necessary department activities.
  • May be required to be on-call for critical systems to provide tier 3 support. All such work will be covered by the requirements of the on-call policy.
  • 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
  • Undergraduate degree or equivalent experience in Information Systems, Engineering, Business Administration or Sciences

  • Knowledge, Skills and Abilities
  • 3-5 years of experience in system administration of Quality / R&D and other Scientific Systems / Applications (such as LabWare LIMS, Empower, ARGUS, Standalone Lab Systems (FTIR, Titrator, Analyzer, ChemStation, SOTAX,Image Analyzer,etc)

  • Strong working knowledge of laboratory processes including cGMP's in a pharmaceutical environment
  • Familiar with 21CFR part 11 ERES requirements
  • The ability to analyze and document business requirements and processes. Translate business requirements to Quality and R&D solutions.
  • Create / Update solutions and implement them via configuration and enhancements.
  • Demonstrate advanced, concise and clear written and verbal communication skills in a variety of settings and styles.
  • Shows excellent listening skills with ability to follow instructions and guidelines clearly.
  • Demonstrates ability to make critical decisions, solve and troubleshoot problems based on analysis, experience and judgement.
  • Originate or initiate new and unique ideas to resolve business / technical problems.
  • Functions in a fast paced and continuously changing environment.
  • Shows excellent organizational and time management skills with ability to manage multiple priorities to accomplish objectives and goals, anticipating and adjusting for problems and interruptions / roadblocks.
  • Displays excellent interpersonal skills.
  • Exhibits excellent presentation skills in a variety of settings with business or technical users in both small and large groups.
  • Delivers training and / or creating training materials on business or technical topics.
  • Demonstrates ability to consistently produce accurate, complete and thorough work of high quality.
  • Proficient in the operation of Microsoft Operating Systems and Microsoft Office Systems (Word, Excel, PowerPoint, Outlook)
  • Understanding of database systems such as Oracle Database and Microsoft SQL database and advanced query language.
  • An understanding and ability to configure TCP / IP network connectivity between systems.
  • An advanced understanding of security of data systems for the protection of Apotex's electronic assets, intellectual property and privacy.
  • Experience in developing and implementing complex data exchange technology processes between information systems.
  • Experience in creating / developing a moderate to complex functional requirement mapping to an Information System based on user requirements.
  • Knowledge of project management methods
  • Experience
  • Minimum of 5-8 years combined experience in Pharmaceutical / Process Industry, Consumer Packaged Goods, Information Systems, or Management Consulting Environment

    At Apotex, we are committed to fostering a welcoming andaccessible 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.

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