Officer, Cal & TM, Eng&Maint-ARPL-ED AR

Job Summary

Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination, online documentation and other Engineering GMP activities as needed or requested by the organization. Responsible for projects and other activities as assigned.

Job Responsibilities

1. Execute all engineering operation as per established ARPL standards and procedures.
2. Reports to Deputy Manager – Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities.
3. Execute in co-ordination with the user departments for calibration instruments related issues / problems and ensuring completion of calibration work orders.
4. Execute / supervise with the help of contractor’s on daily basis or as and when required for follow up and completion of calibration and other engineering cGMP documentation activities and projects.
5. Execute / supervise the engineering department online documentation all time with respect to Risk Assessment preparation and approval / Calibration / Thermal Mapping/ Training / Logbooks.
6. Planning of calibration and thermal mapping activities as per the schedule.
7. Execute calibration of different type of instruments like Electrical, Electronics, Mechanical devices.
8. Prepare Performance Qualification protocols and reports in line with the cGMP requirements.
9. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department personnel.
10. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents.
11. Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering.
12. Works as a member of a team to achieve all outcomes.
13. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
14. Execute / supervise the engineering department online documentation all time with respect to Equipment / Instruments Calibration, Thermal Mapping & Qualification activities.
15. Address and resolve escalated complaints & grievances from user department.
16. Performs all work in accordance with all established regulatory and compliance and safety requirements.
17. Notification creation, Confirmation, and TECO updation for calibration and thermal mapping work orders in SAP PM module.
18. Follow up with cross functional team for on time closure of CAPA, CCR, deviations with respect equipment qualification.
19. All other duties as assigned.

Job Requirements

• Education
  • Minimum Diploma in Engineering
    
    
• Knowledge, Skills and Abilities
  • Should have Knowledge in Calibration, Thermal Mapping and its related documentation.
  • Should have good interpersonal and communicational skills.
  • Should have hands on experience in SAP, MS Office etc.
  • Strives to drive projects related to engineering systems effectively.
  • Knowledge on ISPE, ISO and WHO
  • Should have exposure to any of the regulatory audits like USFDA, HC, MHRA, TGA, etc.,
    
    
• Experience
  • Minimum 02 Year of experience for Bachelor's degree or 04 Years of experience for Diploma in Engineering in a pharmaceutical industry.