Apotex Inc.

Operations

• Support daily results for assigned Shift in the Distribution Center
• Meet targeted objectives in safety, quality, service, and communication
• Direct staff in performance of their job tasks
• Train and develop Associates
• Observe, review, and analyze warehouse processes
• Establish good communication channels between employees and leadership

Operations Coordinator

• Carry out the process and cleaning activities with compliance as per production planning
• Performs all work in compliance with Code of Conduct, Business Ethics, related policies with the legal and regulatory requirements that apply to our job activities
• Works as a member of a team to achieve the goal
• Operates in accordance with Code of Conduct, Business Ethics, all established regulatory compliance and safety requirements
• Execute daily tasks in a way that upholds the following values: collaboration, courage, perseverance, and passion
• To follow good manufacturing practices and Good documentation practices
• To perform the cleaning activities as per the GCR’s
• To ensure and execute that the SAP transactions are done as per work instructions
• To report and record the deviations observed during the activity
• To follow the safety procedures during working
• To maintain a good housekeeping of the plant and surroundings
• To carry out safe disposal of spent and solid waste as per EHS norms
• To undergo training and active participation in the following areas. Unit operations. Good Manufacturing Practices. Safety Report abnormalities in the areas of GMP, Safety, Operations etc., to the immediate reporting officer / supervisor

Junior Chemist – Production Operations

Engineer

• Assist with improvements to production safety, quality, capacity, reliability, cost per 1000 dosages, customer service, and regulatory compliance in the Production department.
• Work closely with Production Technicians and the Production Technical team to understand and analyze production processes and equipment in order to make continuous improvements focusing on Safety, Quality and Productivity.
• Manage resources to complete projects on schedule and create contingency plans to ensure minimal production impact.
• Liaise regularly with Production Operations, Engineering, and Quality Assurance and SHE group to coordinate project activities.
• Follow Change Control requirement, coordinate the installation and commissioning of production equipment, including completing equipment installation and operational qualifications (IQ/OQs).
• Seek out issues and recommend solutions for improvements in production processes, reliability and compliance.
• Generate maintenance and operational Standard Operating Procedures (SOPs), as required.
• Ensure compliance with Current Good Manufacturing Practices (cGMPs), SOPs and Safety Standards.
• Collaborate as a team member to achieve outcomes.

Student Engineer, Production – 12 months

Director

• Responsible for providing high – level administrative support and assistance to the Managing Director and/or other assigned leadership staff
• Assume the duty of clerical and administrative support to optimize workflow procedures in the office
• Assist the Managing Director by planning and distributing information and performing numerous duties
• Schedule meetings, take notes, and record minutes
• Write correspondence, prioritize emails, handle visitors
• Make travel arrangements and prepare reports
• File and organize documents and perform basic bookkeeping tasks
• Act as point of contact among executives, employees, clients, and external partners
• Manage information flow in a timely and accurate manner
• Manage executives’ calendars and set up meetings
• Accurately record minutes during meetings
• Organize and maintain the office filing system
• Prepare financial statements, reports, memos, invoices, letters, and other documents

Assistant Manager – Directors Office

DevOps Engineer

• Responsible for implementing and leading strategies to maximize uptime, performance and lifespan of assets
• Define, develop and execute the Reliability Strategy for all GMP and non-GMP assets
• Work with international site engineering leads to strengthen and harmonize the reliability program
• Lead root cause analysis and corrective action, drive predictive and preventive maintenance programs
• Implement digital reliability tools and optimize asset performance while ensuring regulatory compliance
• Engage with industry experts to stay current on best practices and embed new reliability engineering advancements into continuous improvement objectives
• Develop a strong safety culture that encourages taking the right amount of time to perform each task safely
• Participate and lead performance conversations with employees

Director, Reliability Engineering

Manager

• Perform Analytical activities in QC & AO department
• Sampling of Raw Materials, Packing material, Intermediates, and Finished Products
• Execution of Method validation / Method transfer activity
• Maintaining & monitoring analytical method validation and cleaning validation documents
• Calibration of analytical instruments as needed
• Analysis of Raw Materials, In-Process, packing materials, and Finished Products on request
• Documentation of all works as per relevant SOP
• Ensuring compliance with good laboratory and safety practices

Junior Manager – Quality Control Testing

Compliance

• Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products in international markets.
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
• Handling of change control review (CCR) related activities like confirmation on change assessment, document verification and closing of RA approval tracker.
• Supporting and/or coordinating regulatory affairs projects, as assigned.
• Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.
• Review applications to ensure one cycle approval.
• Support leaders in developing robust processes and systems to build high quality applications and reduce deficiencies from health agencies.
• Support Global Project Management team on activities related to project planning and execution.

Lead Executive – New Product Development, Regulatory Intelligence

• Supporting the Quality Systems required to ensure regulatory and GMP compliance obligations
• Negotiates with external suppliers on the provisions of the customer Quality Agreements
• Makes decisions in consultation with the Manager, External Quality on respective quality responsibilities
• Responsible for ensuring that Quality Agreements are current for vendors supplying to multiple Apotex Manufacturing Sites
• Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements
• Monitor and track status of Quality Agreements
• Provides support to External Quality Managers in reviewing GMP Quality Documents
• 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

Assistant Manager – External Quality

• 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.
• To be well disciplined & maintain the same in the production department.
• To maintain the safety and housekeeping practices at work place.
• To ensure and follow good and online documentation practices.
• To ensure proper labeling procedure wherever applicable as per procedure.
• To ensure that cleaning the area as per related SOP 's are conducted and maintained as per proper cleanliness.
• To ensure the Calibration/Preventive maintenance of the equipment as per the schedule.
• To maintain and ensure cleaning and operation activities are performed as per procedure.
• To maintain the batch as per instruction given in batch document / procedure.
• To ensure material movement is conducted as per procedure.
• To ensure training of our self on current version of procedure prior to perform activity.
• To perform the activities assigned to him by the concerned section seniors or by his superiors in area.
• To follow the cGMP practices.
• To showcase the value of collobaration with own/other departments to complete the work assigned.
• To escalate immediately to concerned superior / manager for any deviation / non-compliance /abnormal observation.
• Shall always be ready to accept new challenges & multifunctional activities.
• Shall always stick to the time line provided or assignment given by superiors, to avoid any delays and any non-compliance.
• 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.
• To plan the production activities as per the weekly plan on daily basis & deliver the same to down level for its execution.
• To supervise the production process to produce quality formulation at optimum cost and within the time limit.
• To plan for various activities of the process and get it done within the specified time.
• Also maintain the online documentation related to production activities .
• To allocate the Job responsibilities for operators, housekeeping & contract labours in production area.
• To train the concern members on the related SOP’s , newly updated SOP’s , cGMP & documentation practices.
• To supervise the process validation & cleaning validation activities as per protocol in co-ordination with QA/QC.
• To ensure that your team members are disciplined and adhere to all the compliance and HR policies.
• To ensure that as a people leader you manage your team members with utmost diligence.
• To ensure that your team members complete all the assigned activities well within the given time line.
• To ensure that all your team members adhere to appropriate gowning and personnel hygiene practices without fail.

Assistant Manager – Production

• Coordinate within team and third-party manufacturing/development sites for co-development projects
• Author/Review of dossiers, deficiency responses and supplements/variations to various Regulatory Authorities
• Responsible for coordinating internally and externally for New Product Launch of Co-development projects
• Responsible for quality eCTD/CTD submissions to various Regulatory Authorities
• Assess and provide regulatory strategy for changes proposed by different third-party manufacturers for co-development products
• Collaborate as a team member to achieve outcomes
• Ensure personal adherence with compliance programs and policies

Senior Manager, Regulatory Affairs

• Oversee Material and Product Disposition
• Manage Quality Investigations and Assessments
• Ensure compliance with GxP and regulatory standards
• Lead Quality Operations team and support business needs

Associate Director, Quality Operations

QA Engineer

• Development, execution and maintenance of effective Quality Systems and ensuring Compliance
• Responsible for supporting Quality Culture through Compliance and Quality System program/system scheduling, execution and monitoring for effectiveness
• Manages audit program by scheduling and leading self-inspections
• Ensures appropriate corrective and preventative actions are taken to close-out audit reports
• Conducts external audits
• Develops, schedules and delivers the on-going GMP training and certification programs
• Writes, updates and reviews Standard Operating Procedures and risk assessment reports
• Completes compliance impact assessments and participates in or coordinates implementation of major system changes

Compliance QA Specialist

• Responsible to ensure quality products are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP)
• Provide continuous quality oversight on the production floor to support real-time, compliant decision-making
• Serve as QA Subject Matter Expert for aseptic practices during sterile manufacturing
• Perform routine inspections of production and packaging areas to ensure adherence to established standards and procedures
• Initiate, lead, and support deviation investigations, non-conformances, and CAPA implementation to ensure timely, compliant resolution
• Review and approve production and batch documentation, focusing on sterile manufacturing records and data integrity
• Coach and mentor production and quality personnel on aseptic practices and GMP expectations

Associate, QAIP

Research Scientist

• 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 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.

Research Scientist – Analytical Development

Financial Planning and Analysis

• Provide in-depth financial support and counsel to Apotex Corp leadership team by aiding financially sound decision making
• Lead the development, review, and governance of GTN forecasts at product, portfolio, and consolidated levels
• Develop and manage short-term and long-range cash flow forecasts tied to sales, GTN, and payment timing
• Oversee financial planning deliverables including AOP (Annual Operating Plan), forecasts, and cash forecasting
• Ensure forecasts and accruals comply with GAAP/IFRS, SOX controls, and internal policies
• Prepare executive presentations and other ad hoc analysis as required