Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

The Specialist, Global QC Electronic Lab Documentation Systems is responsible for the maintenance of the Global laboratory documentation and data management systems within the Apotex Corporate structure, including the creation, revision and review of  LIMS static data for R&D and commercial products. Perform assessment of all changes for impact to LIMS static data, documents and methods. Additional responsibilities include providing laboratory document and LIMS data support and guidance to internal and external customers. Responsible for product launch readiness and implementation of tech transfer packages for NPD, PLCM, MLCM and site transfers.

Job Responsibilities

  • Create and revise LIMS documents (CofAs, Test Profiles) and Packaging CofAs, Stability protocols and Test Methods in the corporate document management systems for R&D and commercial products as required per change control activities.
  • Perform peer review of documentation (i.e. methods, SOPs) and LIMS static data changes for accuracy and compliance with departmental, corporate and regulatory guidelines, and provide feedback as required.
  • Route electronic documents through document management and laboratory information management systems to secure history and allow items to become available to subsequent users for re-editing purposes in a controlled manner.
  • Initiate change controls in support of the creation/revision of specification documents, methods, and LIMS master data.
  • Provide timely solutions and communicate decisions on technical support issues to internal and external customers including the troubleshooting of system & static data issues.
  • Perform impact analysis on all proposed business changes to assess full impact on existing LIMS functionality & business processes.
  • 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.
  • Draft and revise Global QC departmental SODs/WIs/GSOPs/GSUMs. Assign training plans for Organization units in SAP.
  • 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.
  • Monitor the corporate document collection for LIMS CofAs, Test Profiles and methods to ensure that electronic versions are current for viewing purposes. Support any upgrades/changes for improvement to the corporate document collections for LIMS CofAs, Test Profiles and methods by testing upgrades/changes made by GIS and participating in validation activities as required.
  • Develop & maintain expert working knowledge of LIMS functionality through software upgrades & ongoing project implementations.
  • Coordinate tech transfers from R&D to the commercial environment, including management of activities for the creation of Water-mark and commercial specifications.
  • Implement documentation under the MLCM project in coordination with AO and RA.
  • Ensure timely publishing of all specifications once regulatory NOC approval has been received.
  • Perform all work in compliance with current SODs, GSOPs & GMPs.
  • Issue change requests in support of group function.
  • Support LIMS projects and initiatives. Attend cross-functional LIMS meetings as required
  •  Develop and maintain effective working relationships with internal and external customers.           
  • Work as a member of a team to achieve all departmental/company goals and outcomes.
  • Perform all work in support of Corporate Values of Pride, Accountability, Integrity and Diligence. Demonstrate strong and visible support of corporate values.
  • Perform all work in accordance with all established regulatory, compliance and safety requirements.
  • All other duties as assigned.

Job Requirements

  • Post-secondary education required; University degree in science discipline preferred.
  • Minimum 4 to 10 years working experience in a pharmaceutical lab environment.
  • 4 to 10 years senior experience as a chemist or analytical data reviewer in a laboratory environment preferred.
  • Progressive lab experience in the pharmaceutical industry, including working knowledge of HPLC and GC testing is preferred.
  • Expert working knowledge of business processes for change control, LIMS static data design, analysis building & validation, product specification, method management & laboratory testing is an asset.
  • Experience in configuring, validating & revising static data in the LIMS is an asset.
  • Strong understanding of lab instrument software used by the laboratories & their interface to LIMS, including usage of LIMS Basic code, change control systems and document management systems is an asset.
  • Expert user knowledge of software packages (eg. Word, Excel) is an asset.
  • Ability to interpret and draft new test methods and LIMS analysis templates as per compendia (USP, BP & BP).
  • Broad working knowledge of business processes and activities involved in the monitoring of Submission to Launch projects.
  • Strong working knowledge of the coordination activities required between R&D and Commercial areas for ongoing support of Analytical Documentation Tech Transfer, PLCM and MLCM processes.
  • Familiar with current Launch Databases for the management of Launch projects.
  • Understanding of GMPs & GDPs.
  • Ability to co-ordinate and complete projects/project tasks within strict timelines.
  • Strong interpersonal skills and team work skills
  • Ability to be flexible and multi-task in a rapidly changing environment.
  • Strong change management skills; preparing for and facilitating the implementation of change.
  • Strong verbal and written English communication skills.

 

 

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.

 

from Apotex – Scientific & Regulatory Affairs http://bit.ly/2wtFRJr
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About Apotex

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.

Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.