Roles and Responsibilities Manage end-to-end HR operations, including employee data management, payroll processing, benefits administration, and compliance with statutory requirements. Oversee the entire employee life cycle from recruitment to separation, ensuring seamless execution of HR processes. Ensure accurate and timely maintenance of employee records in SAP SuccessFactors (SF) system. Collaborate with stakeholders to identify process improvements and implement changes to enhance efficiency and effectiveness. Provide guidance on company policies, procedures, and best practices to employees at all levels. Desired Candidate Profile 8-10 years of experience in HR Operations or related field. MBA/PGDM degree in HR/Industrial Relations or equivalent qualification preferred. Strong understanding of Employee Data Management, Payroll Processing, Benefits Administration, Compensation & Benefits concepts. Proficiency in using SAP HR modules such as Employee Central (EC), Global Payroll (GP), Time Management (TM).

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. 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. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. 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 M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. 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. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. 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 M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 3 to 6 years of experience in GMP regulated pharmaceutical industry.

Job Summary Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance continued supply of Apotex products. Also responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established with R&D, Quality, Operations and the Regulatory Market Affiliates/customers (Caribbean, EMEA, GCC, LATAM, APAC and any other international markets as assigned) and Regulatory partners at Global Apotex sites. Responsible for coaching team members via sharing of technical knowledge/expertise. Job Responsibilities Responsible for planning workload / projects (i.e. change assessments, submissions, training plans, deficiency responses, audits etc.) for international / rest of world markets and managing processes to ensure objectives of department and submission and approval timelines are met. Prioritizes projects in support of commercial business needs. Ensures supply continuity via timely post-launch variation submissions and strategic regulatory execution for international markets. Handling of deficiencies received from Apotex Affiliates and/or customer and international health regulatory agencies for post-launch variations. Ensures timely PLCM project approvals through quality submissions and monitors agency reviews with affiliates. Develops departmental standards and operating policies and procedures. Provides technical guidance in the review and evaluation of submissions to ensure overall quality and compliance of work. Represents Regulatory Affairs in cross-functional team meetings and provides impact analysis in relevant forums associated with PLCM to support ongoing commercial supply of product. Supports Corporate Business processes (change control, compendia etc.). Develops & proposes regulatory solutions and escalate action plans for identified product issues to mitigate risks, as required. Challenges the status quo. Develops and maintains effective relationships with external vendors, suppliers, business partners and internal stakeholders in order to ensure business needs are met. Implements business objectives, R&D initiatives and regulatory strategy focusing on process improvements. Regular interactions with stakeholders to discuss on expectations, deliverables/priorities and provide solutions to regulatory issues and/or problems. Monitors regulatory changes, communicates trends, and updates global Apotex practices for compliance. Provides guidance and participates as required in recruitment, training, developing and effective management of ongoing performance of regulatory individuals. Manages compliance activities (including but not limited to audit preparation, regulatory information management systems and regulatory info supporting quality management systems) for global regulatory affairs teams and is responsible to ensure that consistent and compliant practices are followed at all Apotex sites. Contributes and encourages team members towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect. Works as a member of a team to achieve all outcomes. Completion of all the assigned trainings in timely manner. Supervises work of direct-reports, assesses training needs, conducts performance reviews, and implements development plans. Participates and leads performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees. Fosters trust through open communication, builds relationships, and pursues leadership development via feedback. Cultivates a trust-based culture, enabling employee growth aligned with core values. Utilizes networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. Ensures adherence of team members (direct reports) with all compliance programs and company policies and procedures. All other duties as assigned. Job Requirements Education A Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar. Knowledge, Skills and Abilities Must possess detailed knowledge of the technical, quality compliance, and global regulatory requirements. Excellent communication, presentation, and interpersonal skills. Excellent Leadership, negotiation, problem-solving and conflict management skills. Demonstrated experience in supervising, influencing, and coordinating the complex activities and interaction of staff, including direct and non-direct reports. Strong organisational skills; ability to work independently as well as in dynamic team environment. Strong ability to lead a team of professionals. Demonstrated knowledge of the generic new product development and post approval management process. Excellent understanding of Project Management principles and practice in a complex environment. Excellent oral/written communication in English. Knowledge of recent updated Guidance s of Health agencies is a must. Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software). Experience 15+ years progressive experience pharmaceutical industry. 10+ years regulatory filing experience with exposure to PLCM & compliance activities for Finished Dosage forms. 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. 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.

About Apotex Inc. Job Summary Responsible for Calibration, Thermal Mapping, 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 Deputy Manager - Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities. Execute in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance work orders wrt instruments. Co-ordinate for all engineering department trainings as per established procedures. Execute / supervise with the help of contractor s on daily basis or as and when required for follow up and completion of calibration, thermal mapping, Qualification and other engineering cGMP documentation activities and projects. Execute / supervise the engineering department online documentation all time with respect to Risk Assessment / Calibration / Thermal Mapping / Planner / Logbooks. Update master calibration schedules, Thermal mapping schedules in SAP, update calibration records, calibration reports review and archival. Prepare Performance Qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department 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. Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory and compliance and safety requirements. Follow up with cross functional team for on time closure of CAPA, CCR, Deviations / investigations with respect to calibration and Thermal mapping. Notification creation, Confirmation, and TECO updation for PM & CM work orders in SAP PM module Execute Master data related activities in SAP. Preparation and review of Risk assesments. All other duties as assigned. Job Requirements Education Bachelors degree in Engineering. Knowledge, Skills and Abilities Should have knowledge in Calibration and Thermal Mappping and its related Documentation. Should have knowledge in QMS documentation. Should have knowledge in utilities systems and equipment s. Should have knowledge in Preventive maintenance process. Works effectively towards achieving the engineering compliance. Should have good interpersonal and communicational skills. Hands on experience in Track wise application, SAP and MS Office etc. Should have knowledge in ISPE, ISO and WHO Guidelines with respect to Calibration and Thermal Mapping process. Should have audit exposure to any of the regulatory audits like USFDA, MHRA, HC and TGA. Strives to drive projects related to engineering. Experience Minimum 8 years experience 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.

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.

About Apotex Inc. 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.

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/Bachelors 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.

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 CCRs 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 Deputy 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. 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 protocol 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 guidance of scientists, 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. 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. 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, 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 SOPs, 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 3-4 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. Job Summary Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipment s within the specified limit and updation of work orders online. As per maintenance work request / corrective maintenance work orders , completion of the activity within the time line. To give training to new technicians for maintenance activities.Responsible for Preparation and review of SOPs and relevant Formats, QMS and other Engineering GMP activities and other activities as assigned. To maintain relevant log books as per cGMP standards. Installation, modification, repair, planning and executing upcoming projects, Qualification, online documentation, preparation of documents and review of documents as per SOP Job Responsibilities Execute all engineering operations as per established ARPL standards and procedures. Adhering to cGMP procedures as per the company policy. Compliance to Safety & Quality standards maintained within the company. Adherence to the departmental procedures. Complaince to the Online Documentation and Good Documentation Practices. Adherence to the Preventive Maintenenace schedule, AMC Schedule and ensuring the quality compliance. Execution of Preventive Maintenance of Process, Packing, Warehouse, Microbiology Equipments as per the approved schedule. Handling the Maintenance related activities within the process area and in service areas. Ensuring completion of Maintenance Work Request in co-ordination with user department. Work Request Printing , Confirmation for PM and Corrective Maintenance in SAP-PM Module. Carrying out the AMC of machines in coordination with vendor as per the schedule. Ensuring the execution of all scheduled Preventive Maintenance of equipment s are performed within defined time limits as per the approved schedule. Monitor in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance requests / corrective maintenance work orders. Executing / Supervise with the help of contractor s on daily basis for follow up and completion of maintenance activities. Ensuring and maintaining engineering inventory management / up keep of minimum stock availability for engineering spares. Execute / supervise / monitor with the help of external agencies for periodic calibration of various instruments & equipment s. Prepare / Check and review planned preventive maintenance schedules, validation protocols and reports in line with the cGMP requirements. Providing all required maintenance support to ARPL as per the departments requirements and operates in full compliance with all regulatory requirements and according to established safety norms. As per requirement creating material management requisition in SAP for material procurement related to process engineering. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS officer. Plan/Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements Regular checks on My Training Plan and ensuring the adherence to training requirement as applicable Demonstrate Behaviors 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 Of Mechanical Engineering / Electrical Engineering / Instrumentation Engineering. Diploma in Mechanical Engineering / Electrical Engineering / Instrumentation Engineering. Knowledge, Skills and Abilities Should have good knowledge in engineering activities and handling the GDP and GMP documents Should have good interpersonal, writing and communicational skills Should have good knowledge in Engineering change management. Should have sound Knowledge in SAP PM/ MM modules. Should have adequate knowledge and skills in QMS activities Hands on experience in SAP, Excel, Ms project etc. Strives to drive projects related to engineering. Skills in Project and Plant Maintenance. Experience Minimum 05 years for Bachelor of Engineering OR 8 years for Diploma in Engineering 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.