Apotex Inc.
Website:
apotex.com
Company:
https://www.linkedin.com/company/apotex-inc-
Seniority: Not Applicable
Industries: Pharmaceutical Manufacturing
Job details:
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .
Job Summary - Preventive Maintenance:
- Execute and oversee the timely completion of Preventive Maintenance (PM) schedules for all equipment’s.
- Minimize unplanned downtime by identifying potential equipment failures through regular inspections and condition monitoring.
- Facility and Utility Maintenance:
- Ensure the uninterrupted supply of facility utilities (HVAC, Water Systems, Compressed Air, Steam etc..) as per the requirements.
- Operational excellence and coordination:
- Act as a technical bridge between Production, and other cross functional departments to ensure smooth plant functioning.
- Compliance, GMP and Safety:
- Strictly adhere to Good Manufacturing Practices (GMP) and APIPL standard operating procedures (SOPs).
- Maintain meticulous documentation, including maintenance logs, work orders etc.., ensuring they are "audit-ready" at all times.
- Implement and follow all Environment Health and Safety (EHS) protocols, and the use of Personal Protective Equipment (PPE).
Job Responsibilities
- Report day-to-day operational and engineering activities to management in compliance with cGMP and documentation requirements.
- Plan, schedule, and coordinate daily engineering activities with Production and other departments to ensure uninterrupted and compliant plant operations.
- Conduct routine discussions with engineering team members to plan, execute, and monitor assigned activities.
- Ensure equipment availability for manufacturing operations while minimizing downtime through effective maintenance planning.
- Investigate equipment breakdowns, perform root cause analysis, and supervise corrective maintenance of critical equipment.
- Ensure all maintenance and breakdown activities are executed in accordance with approved procedures and cGMP requirements.
- Respond promptly to equipment failures to restore operations while maintaining product quality, safety, and regulatory compliance.
- Installation and commissioning of process and utility equipment’s in accordance with approved procedures and regulatory requirements.
- Ensure preventive maintenance programs are implemented as per approved schedules and documented appropriately.
- Monitor, execute, and maintain records for all annual service and maintenance contracts in compliance with approved agreements.
- Coordinate with vendors for material supply as per approved purchase orders and in alignment with interdepartmental requirements.
- Review & verify utility logbooks, checklists, schedules etc.., to ensure accuracy, completeness, and regulatory compliance.
- Ensure safety instructions and mandatory training are provided to contractors, service personnel, vendors, and visitors prior to commencement of work.
- Ensure availability and proper use of required personal protective equipment (PPE) at all work locations.
- Implement and enforce APIPL safety procedures to ensure a safe working environment.
- Attend and comply with safety, cGMP, SOP, internal, and external training programs as required.
- Perform additional responsibilities as assigned by management from time to time.
- Record and manage all plant maintenance and other transactions in SAP in a timely and compliant manner.
- Perform all activities in compliance with the Company Code of Conduct, Business Ethics, and applicable regulatory and legal requirements.
- Work collaboratively as part of a cross-functional team to achieve departmental and organizational objectives.
- Ensure operations comply with established regulatory, quality, and safety standards.
- Perform duties in alignment with organizational values.
- Carry out any other relevant duties as assigned by management.
Responsabilités inhérentes à l’emploi
Job Requirements - Education:
- Minimum Diploma / BE in Mechanical Engineering.
- Knowledge, skills and abilities:
- Demonstrated technical knowledge and practical skills relevant to pharmaceutical engineering operations.
- Proven self-motivation with the ability to work independently and effectively motivate team members.
- Strong collaborative and interpersonal skills with the ability to work efficiently in a regulated APIPL environment.
- Sound understanding and hands-on experience with regulatory compliance, cGMP requirements, and inspection readiness.
- Ability to interpret, implement, and comply with approved SOPs, policies, and regulatory guidelines.
- Experience:
- 3-4 years of experience in engineering functions.
Exigences liées au poste
At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer 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.
Click on Apply to know more.
