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 creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) for Apotex. Responsible for Primary Technical Writer role for change control process in creation of MMaR and MPaR for Signet and Etobicoke sites. Responsible to escalate any critical issues arising from the MMaR / MPaR while drafting. Job Responsibilities Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) Migration of MPPDs into new MMaR & MPaR templates. Manage own workload and completion of assigned MMaR & MPaR within established cycle time commitments. Execution and Cancellation of documents in Content Server. Responsible for Primary Technical Writer role for change control process in creation of MMaR and MPaR for Signet and Etobicoke sites. Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site. Perform all work in compliance with current SODs and GMPs. Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the Team leader. Develop and maintain effective working relationships with internal and external customers. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration; Demonstrates strong and visible support of our values.. Performs all work in accordance with all established regulatory and compliance and safety requirements. 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 Bachelor’s/ Master’s degree in Science / Pharmacy Knowledge, Skills and Abilities: Should be proficient in MS office tools. Should have excellent verbal & written communication skills. Experience of working on online modules / software would be an added advantage. Working knowledge of a document management system required. Ability to be flexible and multi-task in a rapidly changing environment. Experience Minimum 3-4 years of experience in the 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. Show more Show less

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 creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) for Apotex. Responsible to escalate any critical issues arising from the MMaR / MPaR while Responsible for working on POMS Responsible to Support Manufacturing Execution System Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites. Job Responsibilities Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports). Migration of MPPDs into new MMaR & MPaR Working on MMaR execution in POMS Working with Vendor and GTA to Support Manufacturing Execution System project in Design, Configuration and Master Data processes. Execution and Cancellation of documents in Content Creation and peer review of MDoc’s for Cancellation CCR’s. Drafting and review of MMaRs and MPaRs for Richmond Hill Responsible for Primary Technical Writer role for change control process for cancellation of documents for Signet and Etobicoke sites. Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site. Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites. Manage own workload and completion of assigned MMaR & MPaR within established cycle time Perform all work in compliance with current SODs and Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the Team leader. Develop and maintain effective working relationships with internal and external Works as a member of a team to achieve all Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety Works in a safe manner collaborating as a team member to achieve all 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 Bachelor’s/ Master’s degree in Science / Pharmacy Knowledge, Skills and Abilities: Should be proficient in MS office tools. Should have excellent verbal & written communication skills. Experience of working on online modules / software would be an added advantage. Working knowledge of a document management system required. Ability to be flexible and multi-task in a rapidly changing environment. Experience Minimum 2-4 year of experience in the 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. Show more Show less

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 supporting business processes within Global Business Services, driving program management including but not limited to governance, transition and continuous improvements Job Responsibilities Responsible for operational excellence in line with GBS operating model by driving governance framework as per GBS operating model Drive governance for GBS operational plans Publish operational dashboards. Trend and analyze for governance Track execution of operational actions. Report against plan on outcomes realized from actions Champion Continuous Improvement Initiatives at GBS Drive meeting as per agreed governance framework for all processes Ensure transition excellence by implementing 6D methodology for all process transfers Manage RAID (Risk, Action, Issue, Decision) across GBS for people, process and systems Escalate process risks and issues appropriately collaboratively with the Service Leaders and Operational Leaders Support Quality Management Team for activities as aligned Support regulatory and customer audits, when required Escalate unresolved issues to immediate supervisor 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 Minimum Post Graduate, preferably in the field of Life-sciences Knowledge, Skills and Abilities Excellent communication skills Multitasking and good at analytics Adept with Microsoft office suite of applications Capability to work in a matrix environment Experience 5-8 yrs of similar industry experience 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. Show more Show less

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 creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) for Apotex. Responsible for Primary Technical Writer role for change control process in creation of MMaR and MPaR for Signet and Etobicoke sites. Responsible to escalate any critical issues arising from the MMaR / MPaR while drafting. Job Responsibilities Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e. Technical Transfer packages; Technical Operations Reports, Validation Reports) Migration of MPPDs into new MMaR & MPaR templates. Manage own workload and completion of assigned MMaR & MPaR within established cycle time commitments. Execution and Cancellation of documents in Content Server. Responsible for Primary Technical Writer role for change control process in creation of MMaR and MPaR for Signet and Etobicoke sites. Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site. Perform all work in compliance with current SODs and GMPs. Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the Team leader. Develop and maintain effective working relationships with internal and external customers. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration; Demonstrates strong and visible support of our values.. Performs all work in accordance with all established regulatory and compliance and safety requirements. 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 Bachelor’s/ Master’s degree in Science / Pharmacy Knowledge, Skills and Abilities: Should be proficient in MS office tools. Should have excellent verbal & written communication skills. Experience of working on online modules / software would be an added advantage. Working knowledge of a document management system required. Ability to be flexible and multi-task in a rapidly changing environment. Experience Minimum 3-4 years of experience in the 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. Show more Show less

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 the effective and timely execution of the material planning & production, lab scheduling . Regular review of materials inventory for expiring material, and determine re-tests. Creation of Production and Lab Scheduling, MRP Controllers, Logistics personnel, and Procurement personnel within their area and at other sites of the plant . where synergies and common issues exist to obtain best value for the organization. Job Responsibilities Collaborate with cross functional team (Production ,Lab, Warehouise and Logistics) Identify and drive continuous improvement opportunities to streamline process and improve accuracy and efficiency within operations. Should have knowledge of Supply Chain and Materials Management Systems Ability to forge positive relationships and communicate effectively with all levels of management and with all departments Show initiative by undertaking self-development activities, seeking increased responsibilities, and Well known with SAP/ERP/S4 HANA softwares Overall accountability to ensure and maintain RM readiness to execute monthly manufacturing plans including liaising with procurement Responsible for lab scheduling to get, Prodction schedule execution, FG releases on time and meet supply commmitments. Handling of Change control, Deviation, and CAPA through QMS Trackwise. Advanced understanding of capacity analysis to determine scheduling limitations using RCCP Tool. Maintain open/continuous communication with documentation, production, validation, warehousing, NPL, purchasing, quality assurance, laboratory and packaging staff to support activities on the production floor. Operate in full compliance with good manufacturing practices, standard operating procedures and department work instructions. Managing Inventory levels to minimize production risk while maximizing inventory turns. Identifying and driving adoption of Key Performance Indicators as they apply to Supply Chain success, as well as providing input to KPIs as they apply to Manufacturing success. Management of supplier relationships and development of partnerships to ensure efficient use of resources and effective material and component supply practices Monitoring open Purchase Orders and Stock Status reports and expediting order fulfillment to ensure on time delivery Leading the internal initiative to implement and maintain an effective and accurate physical inventory system, including ERP transaction accuracy, physical inventory events, and cycle counting as appropriate The key objectives of this role are to develop and lead proper execution of planning strategies in addition to overseeing activities of the Supply Chain Planning Team and directing the Planners to reach optimal operational efficiencies. This candidate must possess excellent information analytic skills. Participates in existing and new product planning processes to assure timely acquisition of materials to support product launches. Establishes annual goals and objectives, (including stretch targets) in coordination with company objectives, and Performs other duties as assigned. manages performance to ensure attainment Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion. All other duties as assigned. Job Requirements Education: Minimum Bachelor Degree holder in Science or Pharmacy. Knowledge, Skills and Abilities Possess sound knowledge in Manufacturing scheduling. Should possess excellent communication skills (Verbal and written). Good interpersonal skills. Right attitude and work temperament. MS office (word, excel and Powerpoint presentation) Hands-on experience in Trackwise application, SAP, Content Server etc. Strives to drive projects related to Quality Systems effectively. Experience - Minimum 5 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. Show more Show less

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 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. Show more Show less

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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 Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Assistant Manager – Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements. Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification. Receipt and review of Qualification Reports and Certificates from qualification service provider. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks. Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents. Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares. Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects. Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory compliance and safety requirements. Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module. Demonstrate Behaviours that exhibit our organizational values 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 duties as assigned. Job Requirements Education Minimum Diploma Engineering/Bachelor's degree in Engineering Knowledge, Skills and Abilities Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation. Having knowledge in QMS documentation. Having knowledge in utilities systems and equipment’s. Having knowledge in Preventive maintenance process. Having good interpersonal and communicational skills. Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification. Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc., Experience Minimum 3 years of experience for bachelor’s degree or 5 years of experience for diploma in engineering in 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. Show more Show less

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 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 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 Environment health and safety Legal compliance, Hazardous waste and other waste management, Waste water treatment and management, documentation, Trainings and EHS projects. Job Responsibilities Execute allotted EHS activities as per established ARPL standards and procedures. Report to Team Leader– EHS for day to day Activities of Job Summary. Preparation, revision and submission of monthly, yearly reports to KSPCB & DoF, documenting the same. Preparation of consent applications and submission of the same to KSPCB. Collection, storage and disposal of hazardous waste and non-hazardous waste. Effective operation of ETPs of SVMP, LVMP, & BEC to comply consent conditions. Effective Utilisation of operation team for running of waste water treatment plants. Conducting the induction training as per schedule and also other EHS related trainings. Responsible on training related activities in TMA (Creation of session and tracking the closure of sessions as per timelines). Initiating, documenting, co-ordinating with engineering team/other team to successfully complete the projects. Attending Regular meeting as per schedule. Issuance of work permits. Involving in safety risk assessment activity. Attending cross functional team meetings. Ensure and maintain safe work place at ARPL all time in coordination with cross functional teams. Execute along with Quality Assurance/User for preparation, Review and implementation of SOPs. Attend training sessions related to cGMP, Regulatory, latest Technical & Industrial developments related to EHS. 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 M Sc (Environmental Sciences) PG Diploma- Industrial Safety Certified Lead auditor in OHSAS:18001:2007 Knowledge, Skills and Abilities Water & waste water management. EHS Legal compliance Hazardous waste management Experience 13 years of experience in Environment Health & Safety department. 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. Show more Show less

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 the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures. Leading and/or coordinating regulatory affairs projects, as assigned. Preparation of submission and approval notifications for applications submitted to Regulatory agencies. Job Responsibilities Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions. Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval. Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets. Accountable for assessment, coordination and compilation of deficiency responses in a timely manner. Works with other functional areas to resolve issues related to information for regulatory submissions. Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable. Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned). Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information. Co-ordinate with third party manufacturers for document requirement for regulatory submissions. Act as a back-up for team members and support as & when required. Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline. Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable). Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems. Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions. 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: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences. Knowledge, Skills and Abilities: Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets. Experience: Candidate should have minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets. 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.

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 Compile annual product quality reviews (APQRs) per applicable SOPs. Collect, analyse and summarize product review data correctly and completely in timely manner. Job Responsibilities Perform Annual Product Quality Reviews (APQRs) compilation as assigned. This includes the following at minimum, as per SOP: Manufacturing Process Overview Batches Released / Rejected APIs, Excipients Changes Test Method and Specification Manufacturing / Process Validation, Equipment and Utilities Qualification Sterility Validation / Qualification (If applicable) Packaging Component Deviations/Changes Compendial Review Deviations Critical In-Process Attributes Analytical Test Results Recalls and Field Alerts, Returns Retention Samples Review Technical Agreements (as appropriate) Marketing Authorizations Variations and Post Market Commitments (as appropriate) Complaints Stability Conclusion and Product Rating Concerns, Recommendations and Issues for Follow-Up Perform complete and correct transactions of the data as per SOP / WI’s. Summarize and trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leader’s queries for APQR summary reports as required. Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. 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 B. Pharm/ M. Pharm/ M.Sc Knowledge, Skills and Abilities Identify system improvement opportunities for data gathering, template content/format, process efficiency. Expert knowledge of SAP transactions used to support the Product Review process. Ensure timely communication of findings to the key business areas. Maintain the tracking system for compilation and review of assigned APQRs. Ensure that the annual product reviews are performed in full compliance with current procedures. Expert knowledge of International regulatory requirements that apply to Product Reviews. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Demonstrated cGMP knowledge. Excellent technical writing, communication skills and interpersonal skills. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Experience Minimum 2-4 years in the pharmaceutical industry with an emphasis on Quality Assurance. 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.

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 Reporting to the General Manager, QA 3rd Party Ops, India, this role is responsible for supporting the Quality Systems required to ensure that Apotex meets its regulatory and GMP compliance obligations for Apotex Suppliers. Support Managers with compliance activities for Third Party Organizations and Customer Operations. Responsible for executing GMP activities related to the corporate governance of Suppliers to global Apotex Manufacturing Sites. Job Responsibilities Negotiates with external suppliers on the provisions of the customer Quality Agreements. Makes decisions in consultation with the Manager, External Quality on the respective quality responsibilities to ensure both parties are compliant to GMP and meet Apotex internal standards. Responsible for ensuring that Quality Agreements are in place and current for vendors supplying to multiple Apotex Manufacturing Sites. Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements and escalate to management when roadblocks occur. Monitor and track status of Quality Agreements. Provides support to External Quality Managers, in reviewing GMP Quality Documents that form part of Product Compliance Files. Reviews third party manufacturer’s Stability protocols and Summary Reports. Reviews and approves third party manufacturer’s Change Controls. Provides support to Customer Operations Manager, in processing customer requests for products manufactured by Apotex for Third Parties. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our Corporate Values: Collaboration, Courage, Perseverance, and Passion. All other relevant duties as assigned. Job Requirements Education Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science Knowledge, Skills and Abilities Must be familiar with overall pharmaceutical manufacturing and quality systems/process. Good knowledge of global GMPs and QA/QC systems associated with the manufacture of human drug products. Excellent written and verbal English communication skills. Excellent interpersonal skills and ability to relate well to internal and external customers. Experience Minimum 8 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms. Experience with international regulations (e.g. Health Canda, US FDA, EU) is an asset. Must be detail oriented, accurate and reliable. Demonstrate personal leadership and accountability. Excellent organization skills and analytical thinking. 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.

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 The Customer Claims dept is responsible for handling all aspects of the claims administration process. The analyst is responsible for maintaining a low outstanding claims balance by issuing timely settlements to customers. This entails investigating new incoming claims as well as clearing older overdue claims. The analyst is also responsible for performing monthly routine duties as assigned and adhoc analysis. Job Responsibilities Calculates and issues timely monthly settlements and reconciles such settlements to customer claims. Analyzes and processes credits for customer claims. Ensures that the amounts being credited are accurate and timely. Provides forecasts of claims as required. Assists accounts receivables in resolving discrepancies with customers by providing analysis. Maintains strong relationships with internal customers by assisting customer requests. Maintains databases and spreadsheets routinely as assigned. Identifies and implements process improvements. Completes special projects and other duties as assigned. Reviews and process purchase orders to core suppliers based on requisitioned requests. Assists in cross-functional teams for cost saving, process improvement initiatives, as needed. Include the following for all Individual Contributors (those who are not People Leaders) 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 University Degree in Business or Accounting. Knowledge, Skills and Abilities Knowledge of a sales organization’s business processes. Demonstrated proficiency in the use of SAP and BW modules Expert in PC based analytical tools Excel and Access. Knowledge of data integration and cross-referencing. Strong team player who works well in a group environment Positive, can-do attitude and results oriented Proven ability to prioritize and multitask Effective communication and interpersonal skills Must possess strong business ethics for handling confidential information and the ability to make independent judgement decisions. Experience Minimum 2 years analytical experience 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.

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 Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. 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 A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. 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.

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 Coordinates sample flow and testing of samples within PD Solid Dose laboratories. Maintains inventory and records related to samples used in the labs. Job Responsibilities Receives, logs and tracks lab samples, requesting these samples from other departments or external sources as required. Log Raw Material, Semi-Finished, and Finished Product samples in LIMS as required. Perform SAP requisitioning, and place laboratory purchase orders as required. Maintains records for all Controlled and Targeted Substances (CTS) substances as per established procedures. Provide sample package (placebo, standards, samples, documentation, etc.) to the labs for testing. Coordinates with external testing laboratories on API and excipient testing as needed. Interacts with Product Development colleagues (e.g. Formulation Development, Analytical Laboratories etc.) to coordinate and help prioritize API, Excipient and batch testing. Plans and prioritizes work to align with project timelines, seeking input from team members (e.g. Analytical Development, Formulation Development, and Project Management etc.). Monitors status and recommends changes when needed to meet customers’ needs. Receives and tracks in-process and finished product samples from Formulation Development and coordinates with Analytical Laboratories for completion of the requested testing. Provides status updates to team members as needed. Evaluates sample / material flow processes and recommends changes or improvements where needed. Ensures that the work is done in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Documents, and established safety standards. Resolves routine issues with internal customers, working with more senior team members for guidance as needed. 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 A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university. Knowledge, Skills and Abilities Excellent oral and written English communication skills. Strong organizational and interpersonal skills. Strong customer service focus. Familiarity with Microsoft application software, proficiency in SAP and LabWare LIMS is an asset. Strong ability to work efficiently in a team environment. Experience Minimum 1-2 years relevant experience. 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.