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.

For more information visit: www.apotex.com

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 personnel.
• 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’s Degree in Instrumentation/Electronics Engineering.
• Knowledge, Skills and Abilities
  • Minimum 6 year experience in industry & out of which 4 years 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.
  • Troubleshooting in PLC ladder logics for Siemens, Allen Bradley, Mitsubishi, Panasonic, Omron.
  • Knowledge and trouble shooting of Pressure transmitters, Pressure Switches, Different types of sensors and other field devices.
  • Configuration and parameterization of AC/DC, Servo drives.
  • Knowledge of communication protocols Ethernet TCP/IP, Profibus, Profinet, Device net etc.
  • Knowledge and understanding of GMP and GEP requirement and guideline.
  • Aware of various OSD process equipment & spares requirements.
  • Using software tools like PLC programming, DCS programming, or SCADA systems, develop and put into practice control plans.
  • Knowledge of codes, standards, and regulations related to instrumentation and control systems, such as ISA, IEC, and NEC.
  • Should Keep abreast on new developments in the field of instrumentation and control systems as well as market trends.
  • Sound knowledge on various equipment suppliers in both India & abroad.
  • Should have good knowledge in engineering activities & handling the GDP & GMP documents.
  • Should have good interpersonnel,writing & communication skills.
  • Should have good knowledge in Engineering change management.
  • Should have sound knowledge in SAP PM/MM modules MS office, etc.
  • Should have adequate Knowledge & skills in QMS activities.
  • Should be able to drive projects related to engineering- Software/Control upgrade of equipments.
  • Skills in handling Project and Plant Maintenance
• Experience

• Minimum 06 years for Bachelor of Engineering.

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.