Sr Exec, Cal&ThrmlMap,Eng&Mnt-ARPL-ED AR

Job Summary

Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities.  Responsible for projects and other activities as assigned.

Job Responsibilities

• Execute all engineering operation as per established ARPL standards and procedures.
• Reports to Deputy Manager – Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities.
• Execute in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance work orders wrt instruments.
• Co-ordinate for all engineering department trainings as per established procedures.
• Execute / supervise with the help of contractor’s on daily basis or as and when required for follow up and completion of calibration, thermal mapping, Qualification and other engineering cGMP documentation activities and projects.
• Execute / supervise the engineering department online documentation all time with respect to Risk Assessment / Calibration / Thermal Mapping / Planner / Logbooks.
• Update master calibration schedules, Thermal mapping schedules in SAP, update calibration records, calibration reports review and archival.
• Prepare Performance Qualification protocols and reports in line with the cGMP requirements.
• Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department personnel.
• Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements.
• Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents.
• Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering.
• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values.
• Address and resolve escalated complaints & grievances from user department.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Follow up with cross functional team for on time closure of CAPA, CCR, Deviations / investigations with respect to calibration and Thermal mapping.
• Notification creation, Confirmation, and TECO updation for PM & CM work orders in SAP PM module
• Execute Master data related activities in SAP.
• Preparation and review of Risk assesments.
• All other duties as assigned.

Job Requirements

• Education
  • Bachelor's degree in Engineering.
• Knowledge, Skills and Abilities
  • Should have knowledge in Calibration and Thermal Mappping and its related Documentation.
  • Should have knowledge in QMS documentation.
  • Should have knowledge in utilities systems and equipment’s.
  • Should have knowledge in Preventive maintenance process.
  • Works effectively towards achieving the engineering compliance.
  • Should have good interpersonal and communicational skills.
  • Hands on experience in Track wise application, SAP and MS Office etc.
  • Should have knowledge in ISPE, ISO and WHO Guidelines with respect to Calibration and Thermal Mapping process.
  • Should have audit exposure to any of the regulatory audits like USFDA, MHRA, HC and TGA.
• Strives to drive projects related to engineering.
• Experience
  • Minimum 8 years experience in Pharmaceutical Industry.