Apotex Inc.
Website:
apotex.com
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
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.
- 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.
- 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
- Diploma/Bachelor of Mechanical/Electrical/Instrumentation Engineering
- Knowledge, Skills and Abilities
- Should have good knowledge in engineering activities and handling the GDP and GMP documents.
- Minimum 3 year experience in industry hands on experience in OSD formulation Production equipment (Wet Granulation, Compaction, Compression, Capsule filling and Coating).
- Capable of managing and troubleshooting of fully automated production equipment. Exposure on Compression – KORSCH and GEA machines and Gerties Roll Compactor will be added advantage.
- 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.
- Should have Hands on experience in SAP, Excel, MS project etc.
- Strives to drive projects related to engineering.
- Skills in Project and Plant Maintenance.
- Should have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA.
- Experience
- 1-2 years experience in pharmaceutical industry
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.
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