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New

Specialist, Global QC Electronic Lab Documentation Systems

APOTEX

This is a Contract position in Etobicoke, ON posted July 30, 2021.

About Apotex Inc.

Apotex Inc.

is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world.

Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.

Apotex Inc.

exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India.

Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc.

focused on biosimilar development; Aveva, an affiliate of Apotex Inc.

fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc.

focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc.

focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties.

For more information visit: www.apotex.com.

Job Summary The Specialist, Global QC Electronic Lab Documentation Systems is responsible for the maintenance of the Global QC laboratory documentation and data management systems within the Apotex Corporate structure, including the creation, revision and review of analytical test methods, In-process Manufacturing & Packaging CofAs, loading of LIMS specifications, process validation and stability test profiles used in the testing and release of commercial and R&D products.

Prepare specifications associated to our Third-Party counter parts and contract manufacturing operation (CMO).

Responsible for the initiation of departmental change controls to support the department and the business needs.

Specialist to support all the departmental initiatives and projects.

Specialist provides peer review Governance activities to support the Global Business Support groups as well as simple technical support as required.

Job Responsibilities Create, revise and review Specifications and revise Analytical Test Methods in the corporate document management system due to ongoing change control activities.

Create, revise and review laboratory documentation for solid dosage, liquid dosage, raw materials and excipients products to support Global and cross-site product transfers to apply common harmonized testing policy for Apotex laboratories.

Assignment of document codes for new specifications, test profiles and analytical test methods.

Route electronic documents in LIMS and Document Management Systems to secure the history and allow items to become available to subsequent users for re-editing purposes in a controlled environment.

Update appropriate Global databases and Change Management Systems to reflect revision history for revised laboratory documents.

Ensure the timely distribution of lab documentation to the appropriate laboratories & external customers by posting to the intranet.

Monitor ApoWeb document collections for CofA’s and analytical test methods to ensure that electronic versions for viewing purposes are current.

Perform the less complex assessments for proposed business changes to specifications and methods.

Initiate change controls in support of the creation/revision of specification documents, methods.

Collaborate with internal customers to resolve laboratory documentation issues.

Perform Governance peer review activities and support the Global Business Support group.

Develop and maintain effective working relationships with internal customers.

Interpret analytical test methods and relevant instructions in order to load and review product specification in LIMS, with supervision.

Develop and maintain detailed working knowledge of corporate document management system, corporate change management systems and LIMS through all software upgrades.

Track all work using designated tracking systems and processes.

Participates in departmental projects and enhancement activities.

Works 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.

All other relevant duties as assigned.

Job Requirements Education Post-secondary education required; University degree in related discipline preferred.

Knowledge, Skills and Abilities Laboratory experience in the pharmaceutical industry.

HPLC knowledge preferred.

Basic understanding of the business processes for change control, product specification, method management & laboratory testing an asset.

Working knowledge of a document management systems and LIMS an asset.

Previous experience in preparing documents in the pharmaceutical industry is preferred.

Ability to investigate problems with guidance.

Ability to interpret Apotex and compendia methods (USP, BP & EP) and load into LIMS Understanding of GMPs, GLPs & GDPs.

Proficient in Microsoft Office software, in a network environment.

Strong organization and report writing skills.

Ability to complete projects with strict deadlines.

Demonstrated knowledge of organizational structure and functions across Apotex and affiliates is an asset.

Well-developed interpersonal and teamwork skills.

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

Strong verbal and written English communication skills.

Experience 3 years working experience in the pharmaceutical laboratory environment using 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.