Sr Executive - Process Maintenance

Apotex Inc.; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Apotex Inc. is seeking a Maintenance Engineer to allocate work to technicians, perform PM activities on process equipment, and ensure timely completion of maintenance tasks. The role includes SOP preparation, online documentation, and review of cGMP compliant records.

You will train new technicians, manage calibration and inventory, and coordinate with external vendors for maintenance projects and instrument calibration in line with GMP standards.

Qualifications

• Bachelor of Mechanical/Electrical Engineering required.
• 3 years’ hands-on experience in OSd production equipment.
• Experience with GDP/GMP documentation.
• Experience with SAP PM/MM modules.
• Familiarity with SAP, Excel and MS Project.
• Knowledge of GMP change management.
• Experience with compression – KORSCH/GEA advantageous.

Responsibilities

• Execute engineering operations per ARPL standards and procedures.
• Adhere to cGMP procedures and safety/quality standards.
• Maintain SOPs, QMS logs and online documentation.
• Plan, execute and supervise preventive maintenance schedules.
• Coordinate with user departments to close maintenance work orders.

Skills

Engineering activities

GDP & GMP docs

SAP PM

SAP MM

Excel

MS Project

Project & Plant Maintenance

Interpersonal skills

Education

Bachelor of Mechanical/Electrical Engineering

Tools

SAP PM

SAP MM

Job description

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.

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
  • Bachelor of Mechanical/Electrical 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.
• Experience
  • 3 years experience for B.E/B.Tech Engineering.

Compensation Data

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.