Senior Executive, Stability Lab (Documentation)

 

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

 

Job Summary

Responsible for reviewing of all analytical data generated in ARD-Test Centre in compliance with cGMP and related SOPs and preparing reports for submission to the Regulatory agencies.

Primarily responsible for creating and revising all analytical test methods (chemical and physical) and specifications generated in Analytical R&D as per current Apotex format and posting the methods on Apoweb. Responsible for the completion of R&D Change Control Requests (CCRs) in Trackwise for method creation to transfer of methods to the commercial site. Responsible for support and completion of R&D CCRs in Trackwise for generation and update of specifications. Also responsible for creating, updating and maintanance of Apotex technical report templates.

This person is seen as a leader and acts as a backup-supervisor for all project updates or queries on submission documents.

Job Responsibilities

• Requests product codes for new projects from Consultant, Financial data Processes (for SAP product codes) or from Supervisor, NPL-Master Prod&Pkg Docs (for product acronyms) and assigns new method numbers for Analytical R&D and ARPL, as applicable, using Excel database.
• Creates and revises analytical test methods generated in Analytical R&D using current method templates, for example: chromatographic methods, physico-chemical test methods, dissolution test methods.
• Assists PD-SD chemists, Chemistry & Compendia associates, and ARD scientific leaders with CCR creation and reviews all associated documents prior to management approval.
• Initiates and supports change controls as relevant to R&D specifications.
• Liaises with Analytical R&D, Commercial labs, QC Documentation group, RA and R&D QA for CCR’s signatures and impact analysis.
• Checks the method files into Content Server and creates workflow in Workflow Manager.
• Posts all analytical methods on Apoweb (Analytical Test methods site), maintains the site archive, and adds all new product/excipient names to the Apoweb.
• Creates and maintains Excel database of R&D analytical methods and the method change histories.
• Communicates the status of analytical method and R&D specifications change control to relevant parties in a timely manner.
• Works with ARD Scientific Leaders and supervisors to ensure test method templates are current.
• Creates, updates and maintains ARD technical report templates (including those for global regulatory submissions).
• Ensures all analytical tests are done according to the test method, GMP, SOP/WI and Guidelines
• Reviews all analytical data generated by ARD-QC lab. Understands the detailed analytical procedures and guidelines.
• Liaise with other units within GRD to ensure that all information required for stability protocol is completed.
• Review the stability protocols in LIMS.
• Reviews the Laboratory investigations and deviations for accuracy, compliance and completeness.
• Reviews analytical data pertaining to the analytical testing of drug substance, in-process sample, drug products and excipients.
• Reviews analytical data pertaining to additional tasks required for the submission such as comparative dissolutions studies, stability studies, photostability studies, dissolution pH & Alcohol Dose Dump studies and impurity surveys.
• Reviews analytical data pertaining to validation and technology transfer of analytical testing procedures of drug substances and drug product.
• Verifies the integrity and traceability of all data reported.
• Ensures the accuracy of calculations and that the test method and relevant SOP’s/WIs have been followed during the performance of the analytical test. · Prepares various analytical summary reports such as comparative dissolution report, stability summary reports, photostability report, impurity surveys, PH dissolution report, Alcohol Dose Dump studies report and test article report for clinical studies. Ensures the above reports with accurate content are published on ERS.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Performs all work in accordance with all esta