Executive, Analytical R&D
4 weeks ago
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.
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Job Summary
Execution of analytical method optimization /development, validation/ verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes( SDC) and other procedural updations.Preparation of method validation/verification protocols and reports.
Job Responsibilities
Execution of Method optimization / development studies. Method validation/ verification of In-house methods, Compendia, SDC, MLCM and Cleaning Analytical methods by adhering to the regulatory procedures. Preparation of Method verification/ Method transfer Protocols and reports. Execution of Method transfer analysis and reporting. Execution of analytical studies related to Regulatory queries/submisiion requirement. Perform all work in accordance with all established regulatory compliance and safety requirements. Responsible for the activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality system. 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
MinimumMSc/BPharm or any equivalent degree.Knowledge, Skills and Abilities
Command on Microsoft-Office (Word, Excel). Knowledge in Method optimization/development activities. Best in effective completion of work activities to meet the time lines. Able to perform multi parameter analysis on HPLC instrument.Experience:
Minimum 3 to 6 years of experience in GMP regulated Pharmaceutical Industry. 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.
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