Executive, E-Lab Documentation

Job Summary

• The Executive is responsible for execution of LIMS change controls within Apotex Corporate structure.
• Maintenance of the Global laboratory documentation and data management systems, including the creation, revision of analytical test methods and In-Process Manufacturing & Packaging CofAs, LIMS CofAs and Test Profiles used in the testing & release of commercial and R&D products. LIMS static data for R&D and commercial products, and the assessment of changes for impact to LIMS static data.
• Act as a technical resource and responsible to escalate any critical issues identified during implementation and review of change controls pertaining to LIMS static data changes.

Responsible for product launch readiness and implementation of tech transfer packages for NPD, PLCM, MLCM and site transfers

Job Responsibilities

• Create, revise and review specifications LIMS documents (CofA, Test Profiles)] and Analytical Test Methods for solid dosage, liquid dosage and raw material products in the corporate document management system in response to ongoing change control activities to support Global product transfers and apply harmonized testing policies for Apotex laboratories.
• Perform peer review of documentation and LIMS static data changes for accuracy and compliance with departmental, corporate and regulatory guidelines, and provide feedback as required.
• Issue document numbers for new specifications and analytical test methods.
• Route electronic documents through document management and laboratory information management systems to secure history
• Review new products and map testing requirements to existing analysis inventory list.
• Liaise with QC and R&D labs, GIS, Global QC LIMS Business Support, Quality, internal & external consultants on new developments & cross-divisional changes for configuration, code, reports and projects.
• Evaluate and initiate change controls in support of the creation/revision of specification documents, methods, LIMS master data and LIMS code/configuration.
• Update appropriate corporate document management and change control systems to reflect revision history for new & revised lab documents
• Ensure the timely posting of LIMS CofAs and Test Profiles to the corporate document collections & to external customers as required.
• Develop & maintain expert working knowledge of LIMS functionality through on-going project implementations.
• Coordinate tech transfers from R&D to the commercial environment, including management of activities for the creation of Water-mark and release commercial specifications.
• Ensure timely publishing of all specifications once regulatory NOC approval has been received.
• Perform all work in compliance with current SODs, GSOPs & GMPs.
• Support LIMS projects and initiatives. Represent R&D and QC LIMS static data/document configuration at cross-functional LIMS meetings.
• Develop and maintain effective working relationships with internal and external customers.
• Manage hard copies of LIMS impact sheets, peer review forms and verification forms for timely storage and availability.
• Scheduling and monitoring of LIMS Review day to day activities.
• Work 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.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• All other duties as assigned.

Job Requirements

• Education
  • Master’s degree in Pharmacy
• Knowledge, Skills and Abilities
  • Experience with Microsoft Office applications. SAP, LIMS, TrackWise an added advantage.
  • Knowledge of GMPs governing documentation in the pharmaceutical industry.
  • SAP experiences an asset.
  • Proficient in the use of Microsoft Office Suite applications.
  • Demonstrated leadership skills.
  • Demonstrated decision-making ability with strong problem solving skills.
  • Expert knowledge of all compendia process as it relates to publication and monitoring of changes in the USP, BP and EP.
  • Strong knowledge of the ICH guidelines.
  • Strong knowledge of regulatory guidelines for FDA and Health Canada.
  • Ability to interpret and independently apply broad testing guidelines as per compendia (USP, BP and EP).
  • Excellent organizational and interpersonal skills with a customer focus.
  • Ability to coordinate and complete projects with strict deadlines.
  • Demonstrated ability to work effectively in a team-based environment.
  • Ability to adapt in a rapidly changing environment.

• Experience
  • Minimum 4-8 years in the pharmaceutical industry with an emphasis on Quality Control, Laboratory Information Management System (LIMS) and analytical data interpretation