Technical Writer, SOD
Apotex Inc
North York, ON
3d ago

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

    Responsible for maintaining the SOD systems for the Signet Campus by :

    1.Organizing and implementing all SOD change requests

    2.Completing a detailed impact analysis on SOD CCRs to ensure that all related SODs affected by a change request are updated

    3.Completing a detailed review of SODs and recommending solutions to develop a final document with accurate and functional content

    4.Maintaining and overseeing the SOD Templates for Signet Campus

    5.Providing on-going SOD support and guidance to internal customers

    Job Responsibilities

  • Organize and implement all SOD change requests to defined deadlines
  • 1.Prioritize change requests as per business needs

    2.Manage and track progress of all SOD revisions using corporate applications such as QMS, Livelink and SAP

    3.Address comments received from TrackWise and Livelink approvers

    4.Ensure all related SODs affected by the change request are updated as needed

    5.Co-ordinate updates with the other areas of the business

    6.Manage complex changes involving multiple SODs, under minimal supervision

  • Complete detailed impact analysis on SOD change requests for overlaps, discrepancies, readability, GDP and cGMP compliance
  • 1.Recommend solutions to resolve inconsistencies to develop a final SOD with accurate and usable content

    2.Determine impact of proposed changes on related SODs and work with the change owner and business SME to identify all changes required to related SODs

    3.Ensure that all requested changes adhere to cGMP regulations and corporate Quality Standards

  • Liaise with all areas of Apotex and its affiliates at all levels of management and non-management to interpret their document requirements and to oversee the resolution of issues for new and revised SODs
  • 1.Issue document numbers for new SODs

    2.Provide e-copies of SODs when requested

    3.Help co-ordinate and manage SOD creations / revisions as well as continuous project support

    4.Develop and maintain effective working relationships with customers

    5.Facilitate meetings to help resolve and provide guidance to content and project issues

    6.Provide coaching to other team members and customers

    7.Provide detailed SOD training status information using SAP transactions

  • Resolve ownership and scope of documents between departments and ensure that SODs reflect Signet Campus as well as departmental processes
  • 1.Collaborate with affected departments to determine common processes and reduce the overall number of documents

    2.Determine gaps and overlaps in the existing document collection and propose solutions

  • Provide expertise to customers on the development of Signet Site SODs by advising on naming conventions, content flow and correlation with the Signet templates and document collections
  • 1.As required, work with customers to map business processes to determine steps in an SOD

    2.Provide technical support for templates and software applications used to maintain the SOD collection

  • Manage the document approval process using Livelink and QMS trackwise
  • 1.Work closely with SOD approvers to ensure that documents are approved in a timely manner in accordance with business needs

    2.Resolve issues that hinder approval of documents

  • Carry out the role of DTC Support for MFG Signet Org units to expedite processing of training rosters, highlight training requirements and gaps for employees, generate and interpret standard reports
  • Execute a project leadership role to meet department objectives
  • Distribute hard copy approved SODs when required -Maintain current and obsolete hard copy files
  • Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities
  • Works as a member of a team to achieve all outcomes
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
  • Performs all work in support of our Values : Collaboration, Courage, Perseverance, and Passion
  • All other relevant duties as assigned
  • Education

    1.Post-secondary education required

    2.University degree in related discipline preferred

    Knowledge, Skills and Abilities

    Required :

    1.Understanding of GMPs and SODs

    2.Proficient in the use of Microsoft Office software in a network environment

    3.Strong verbal and written English communication skills

    4.Excellent organization and writing skills

    5.Excellent interpersonal and team work skills

    6.Ability to complete and co-ordinate projects with strict deadlines

    7.Ability to be flexible and multi-task in a rapidly changing environment

    Preferred :

    1.SAP, QMS, TrackWise and Livelink experience is an asset

    Experience

    1.Three to five years business experience; a familiarity with the pharmaceutical industry and / or other highly regulated manufacturing environment preferred

    2.Hands-on experience of a document management system is an asset

    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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