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.
Post : Senior Analyst, GBS GQC LIMS-GBS-GQC G
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.
• 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.
• 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.
Experience : 4 to 10
Qualification : M.Sc, M.Pharm
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : GBS GQC LIMS-GBS-GQC G
End Date : 30th December, 2021
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