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Master Change Specialist / Documentation Specialist - 18 month contract

Date: Jun 4, 2021

Location: Toronto, Ontario, CA, M1B2K9

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

We are currently seeking a Master Change Specialist/ Documentation Specialist to join the Teva team for an 18 contract.

The Master Change Specialist/ Documentation Specialist will evaluate all Change Requests in line with Teva’s Change Policy to ensure holistic change review and implementation. The Change Specialist with perform creation, evaluation and assessment of a variety of Change Types.  Evaluation of all SME evaluations to ensure alignment with compliance, production, quality and business needs is also required by this role. This Candidate will update and track tasks/change progress through our validated systems to ensure that change tasks are completed to align with both Compliance and Business needs.  The Master Change Specialist has the accountability of not only processing change, but starting change, revising and implementation change from Change Owner and following thru all change controls to ensure completion.  MCS serves as a leader for change facilitation and owns the change upon creation.  This position has a dual role between MCS duties (Artwork, Process Support) and that of a document specialist.  Candidate will also be accountable for facilation of document (Controlled documents, MBR And MPO) updates, circulation for approval and issuance on KT.

  • Responsible for the review, impact assessment and creation of GProjects (Harmony Trackwise) for multiple types of both Teva and Supplier driven changes
  • Responsible to assessment of all evaluations (GCCM Harmony Trackwise) by Subject Matter Experts to ensure not only proper task assignment but validity of evaluation and thus subsequent GCCM requirements
  • Responsible for complete holistic change review to ensure that all required supporting documentation is present with reference to supporting matrix documentation as well as in collaboration with other support department.
  • Responsible for the initiation of all required project related activities in support of Project Management Office related projects.
  • Interface with other departments/subject matter experts to ensure Holistic Change impact. This will also include working with other Teva Sites (US and Europe) to drive change.
  • Responsible for tracking and monitoring of all Regulatory activities to ensure compliance obligations are met, but to also ensure that filing strategies are properly identified.
  • Accountable to ensure that the change is executed as planned. This includes co-ordination of meetings and ensuring collaboration among multiple departments to drive the change forward.
  • Responsible for collaboration with all internal departments to perform Gap Analysis of current systems to ensure they are aligned with Harmony Trackwise for all change impacts.
  • Accountable to hold regular update meetings (as required) to either update key stakeholders or train all users on justification and holistic change requirements.
  • Process updates from approved GCCM into final documentation (MBR, MPO, Controlled documentation). 
  • Route final documentation for approval on KT, track effectivity and ensure project aspects between MCS accountabilities and documentation requirements are linked.

Qualifications

  • College Diploma or Certificate in related field a minimum; Preferred: University Degree in related Science.  PMP Certification an asset.
  • 5+ years experience in a fast paced manufacturing environment (pharmaceutical industry preferred) as a minimum; 5 Years minimum experience in Project Management
  • 5+ years and expert knowledge of pharmaceutical artwork processes.
  • 5+ years experience as a change driver inclusive of holistic review and impact within pharma environment
  • 5+ years and has Expert knowledge in LIMS, ERP, KT  and Harmony Trackwise
  • Expert knowledge with Adobe Pro and form building
  • Capabilities to manage multiple priorities/ processes across multiple sites with high levels of complexity

Function

Quality

Sub Function

Quality Compliance

Reports To

Senior Manager, Quality Assurance

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.