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Consultant, QC Process Support

APOTEX INC.

GTA, ON, CANADA | North York, ON, CANADA
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About Apotex:

 

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!


We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.

 
We’d love to hear how you could contribute to the team!

 

Job Summary: 

 

Maintain the LIMS laboratory documentation & data systems within the Apotex Corporate structure across Richmond Hill, Etobicoke, ARPL & Signet sites:

 

  • Build, validate & test LIMS analyses.
  • Create, revise & review LIMS static data for R&D and Commercial products. This includes the creation & review of R&D and Commercial LIMS product specifications (CofAs/Test Profiles) and related static data objects.
  • Assess LIMS system impacts for static data and document change requests.
  • Cross-train staff on LIMS analysis building, specification loading & review.
  • Provide LIMS technical support & guidance to internal customers & LIMS Project Teams.
  • Develop and deliver R&D end-user training for LabWare LIMS modules.

 

 

Job Responsibilities:

 

  • Build, test &revise LIMS analysis configuration for use in new & existing product testing templates to support ongoing change control activities. This includes the migration of analyses and related static data objects across development, test & production environments in LabWare.
  • Provide ongoing technical support for the LabWare LIMS configuration, including the troubleshooting of system & static data issues.
  • Perform impact analysis on proposed business changes to assess full impact on existing LIMS functionality & business processes.
  • Develop and maintain effective working relationships with internal customers.
  • Develop/revise user requirements for proposed/existing LIMS configuration and document report requests &prepare functional specification documents for IS. Work in conjunction with IS to fully test and challenge code developed by IS in Development and Test environments to ensure business needs are met.
  • Review new products and map testing requirements to existing analysis inventory list. Build new analyses for mapping gaps identified.
  • Coordinate with internal customers & external resources (USP/BP/EP contacts) to resolve product-testing issues.
  • Liaise with QC and R&D labs, IS, QC LIMS Business Support, Quality, internal& external consultants on new developments & cross-divisional changes for configuration, code & reports.
  • Write, revise & execute validation test cases to validate LIMS configuration and report changes created/revised by IS, prior to implementation in the LIMS Production environment.
  • Review LIMS static data created by other LIMS Consultants & Technical Writers for accuracy & compliance with departmental guidelines & provide feedback as required.
  • Propose system enhancements to facilitate better usage of LabWare LIMS across Apotex sites.
  • Provide timely solutions & communicate decisions on technical support issues to internal and external customers & LIMS Project Teams.
  • Deliver internal training to support document template developer role & LIMS change request process.
  • Draft departmental SODs/WIs related to LabWare LIMS static data processes where gaps are identified. Issue change requests to revise existing SODs/WIs for process changes.
  • Provide technical expertise to LabWare projects by developing static data and assisting in user acceptance testing, validation test case drafting and execution & other project-related activities.
  • Create & revise laboratory documentation and LIMS static data for R&D and Commercial solid & liquid dosage products to support cross-site product transfers & to apply common harmonized testing policy for Apotex laboratories & production/in-process data collection.
  • Create and revise LIMS CofAs & Test Profiles in the corporate document management system due to ongoing change control activities.
  • Issue document codes for new LIMS CofAs & Test Profiles.
  • Create & revise LIMS analyses and related static data objects for use in product testing templates to support ongoing change control activities.
  • Route electronic documents in LabWare LIMS to secure history & allow items to become available to subsequent users for re-editing purposes in a controlled manner.
  • Update appropriate corporate document management system to reflect revision history for new & revised lab documents
  • Provide mentoring and support to internal & external customers for LIMS & change management issues.
  • Develop user requirements for proposed configuration and report changes by interviewing subject matter experts and preparing functional & technical specifications.
  • Configure the LIMS for identified changes, including designing, building & testing of static data objects and the testing of new system processes.
  • Develop and deliver LIMS training courses for R&D end-users.
  • Ensure the timely posting of LIMS CofAs and Test Profiles to the intranet document collection & to external customers as required.
  • Monitor intranet document collection for LIMS CofAs and Test Profiles to ensure that electronic versions for viewing purposes are current. Support any upgrades/changes for improvement to the intranet document collection for LIMS CofAs and Test Profiles by testing upgrades/changes made by IS and participating in validation activities as required.
  • Track all work using designated tracking system and process.
  • Monitor the performance of LIMS-related applications (LIMS Dev,Test & Prod environments, intranet document collections for LIMS Blank CofAs and Test Profiles & Doc-Data Trackwise) to ensure that performance levels support  uninterrupted LIMS activity.
  • Develop & maintain expert working knowledge of LIMS functionality through software upgrades & ongoing project implementations.
  • Perform all work in compliance with current SODs & GMPs.
  • Issue change requests in support of group function.
  • Support LIMS projects and initiatives. Represent R&D and QC LIMS static data/document configuration at cross-functional LIMS meetings.
  • Act as back up for QC LIMS Coordinator.
  • Maintain the filing system for LIMS template development work.
  • Perform additional duties as required.

 

 

Job Requirements:

  • Demonstrated leadership skills.
  • Ability to investigate problems independently and propose viable solutions. Demonstrated decision-making ability with strong problem solving skills.
  • Expert working knowledge of the corporate document management system and LIMS is required.
  • Ability to interpret and apply broad testing requirements as per compendia (USP, BP & EP).
  • Previous experience in preparing documents & managing data in the pharmaceutical industry is preferred.
  • Understanding of GMPs & GDPs.
  • Experience in & proficient use of Microsoft Office software, in a network environment.
  • Expert user knowledge of the following software packages for the design, development & maintenance of a standard format for Lab Data & Documents is an asset:   LabWare LIMS, including usage of LIMS Basic code & Doc-Data Trackwise.
  • Strong organization skills and report writing skills.
  • Ability to co-ordinate and complete projects with strict deadlines.
  • Demonstrated knowledge of organizational structure and functions across Apotex and affiliates.
  • Well developed interpersonal and team work skills.
  • Ability to be flexible and multi-task in a rapidly changing environment.
  • Strong change management skills; preparing for & facilitating the implementation of change.
  • Strong verbal and written English communication skills.

 

Education:

  • Post-secondary education required.
  • University degree in science discipline preferred.
  • Minimum 3-5 years working experience in a pharmaceutical lab environment.
  • Progressive lab experience in the pharmaceutical industry, including working knowledge of HPLC and GC testing is preferred.
  • 3-5 years senior experience as a chemist or analytical data reviewer in a laboratory environment preferred.
  • Expert working knowledge of the business processes for change control, LabWare LIMS static data design, analysis building & validation, product specification management & laboratory testing is an asset.
  • Experience configuring, validating & revising static data in the LabWare LIMS is an asset.
  • Strong understanding of lab instrument software used by the laboratories & their interfacing to LIMS.

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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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