Deputy Manager - Eng & Maint

Job Summary

Responsible for Engineering Compliance and QMS including SOP compliance, GSOP, Deviation Investigation,  temporary changes, Training, Internal/External Audit Compliance. Responsible for end to end management of Qualification, Calibration, Thermal mapping and Layouts compliance. Support for engineering new projects, training management and other activities as assigned.

Job Responsibilities

1. Conduct all the Engineering operations following the established ARPL standards.
2. Report to General manager at site regarding all aspects of engineering related operation and documents on daily basis.
3. Ensure no gaps in GLMS / Success Factors and must ensure no training gaps with in the team.
4. Ensure no gaps with respect to QMS documentation and ensure no overdue at any stage.
5. Ensure execution of Qualification, Calibration and temperature mapping, related activities and compliance to the defined procedure.
6. Manage and provide leadership for engineering staff and to ensure for the equipment’s online documentation are maintained for all time.
7. Liaise with the QA department to Co-ordinate for the preparation, development and implementation of SOP’s, qualification and engineering personnel training programs.
8. Train the Maintenance Executives, officers, operators / technicians on cGMP, Regulatory, latest Technical & Industrial developments related to Engineering.
9. To plan and co-ordinate in the execution of projects and facility changes.
10. Planning of Department activity / Annual Budget / Managing work force.
11. Ensuring with the engineering personnel for calibration of instruments / equipment’s / Qualification and re - evaluation of Equipment’s to be performed as per schedule.
12. Ensuring the engineering department on line documentation all time WRT to equipment Qualification / Calibration / Thermal Mapping / Re-Qualification / Re-evaluation / Risk assessment / Investigation / CAPA / Effectiveness checks / CCR / Deviation and Training.
13. Ensure and maintain safe work place at ARPL all time in coordination with EHS Personnel.
14. Implementation / Review / Periodic revision of SOP / Equipment Qualification / Engineering personnel Training programs.
15. Scheduling / participation of training session related to cGMP, Regulatory, latest technical & industrial development related to engineering.
16. Review of facility layouts in the line with regulatory requirements.
17. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in all employees progress toward achieving objects; offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
18. Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leaders while continuously improving leadership capabilities by personally seeking feedback and development.
19. Act as a Subject Matter Expert (SME’s) for the QMS, Qualification, Calibration and Thermal Mapping related Engineering function.
20. Commissioning, Qualification of new and renovated clean room facilities, HVAC & BMS systems.
21. Qualification of the Product contact utilities such as Water systems & Gases.
22. Address and resolve escalated complaints & grievances from user department.
23. Create a culture which values trust and provides the opportunity for employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
24. Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
25. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
26. All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum Diploma in Engineering / Bachelor's degree
• Knowledge, Skills and Abilities
  • Good knowledge of Quality Management system, exposure to audits, Risk Assessment, etc.,
  • Should have knowledge in Qualification, Calibration, Thermal Mapping, Maintenance, Training and its related documentation.
  • Sound have knowledge on various regulatory requirements & interpretation skills.
  • Should have good knowledge on project management.
  • Works effectively towards achieving the engineering compliance.
  • Hands on experience in Track wise application, SAP and MS Office etc..,
  • Should have knowledge on ISPE, ISO and WHO
  • Shall have exposure to any of the regulatory audits like USFDA, MHRA, TGA & HC.
• Experience
  • Minimum 12 Years of experience for Bachelor's degree OR 14 Years of experience for Diploma in Engineering in a pharmaceutical industry.