Specialist, Global Quality Control

5 days ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

**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. Also responsible for the configuration, revision and review of LIMS static data for R&D and commercial products along with the validation and testing of LIMS analysis templates and associated objects. Responsible for assessment of all changes to identify the impact to LIMS static data, specification and methods.

Additional responsibilities include providing laboratory documents 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. Involved in contract manufacturing operation (CMO) activities associated to specifications, methods and testing requirements. Maintenance of the Global QC WIs/SOPs perform audit activities as required as well as provide technical training to business personally internally as well as Globally. Initiation of change controls to support the departmental and business function. Specialist to support all departmental initiatives and projects. Perform Governance activities and complex technical support to the Global Business Support groups.

**Responsibilities**:

- Create LIMS product, analysis and associated templates; revise existing templates due to LIMS change controls and project activities.
- Create and revise LIMS documents CofAs, Test Profiles, Pkg CofAs, Stability protocols and Test Methods in the corporate document management systems for R&D and commercial products.
- Perform peer review of documentation and LIMS static data changes for accuracy and alignment with regulatory guidelines.
- Build, test & revise LIMS analysis configuration for new & existing product templates to support ongoing change control activities. Including migration of analyses and related static data objects across DEV, Test & Production environments.
- Develop/revise user requirements for proposed/existing LIMS configuration. Document & report requests prepare functional specification documents for GIS**.** Work in conjunction with GIS to test and challenge code developed by GIS in DEV and Test environments.
- Provide timely solutions and communicate decisions on technical support issues to internal and external customers related to LIMS configuration, including the troubleshooting of system & static data issues.
- Liaise with QC, 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.
- Initiation of required change controls.
- Perform impact analysis on proposed business changes to assess impact on existing LIMS functionality & business processes.
- Deliver training to support document template developer role & QMS change control process.
- Draft and revise Global SODs/WIs/GSOPs/GSUMs through the corporate change control process.
- Monitor the corporate document collection for LIMS specification, test profiles and methods to ensure that electronic versions are current for viewing and testing purposes.
- Develop & maintain expert working knowledge of LIMS functionality during software upgrades & ongoing project implementations.
- Coordinate tech transfers from R&D to commercial environment, including management of activities for the creation of Watermark & commercial specifications.
- Implement activities for MLCM/PLCM in coordination with AO and RA.
- Timely review and publishing of specifications at receipt of regulatory NOC approval.
- Represent department in daily/weekly PCM, site transfers, launch and project meetings.
- Support all departmental projects and initiatives.
- Support corporate and external audits.
- Perform Governance peer review activities and technical support for the GBS group.
- Develop and maintain effective working relationships with internal and external customers.
- 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 science discipline preferred.
- Knowledge, Skills and Abilities
- 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 a

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