Senior Executive, Eng&Mnt-QMS

Job Summary

Responsible for Compliance, QMS activities such as Deviation investigations, CAPA & Effectiveness checks, temporary changes, SOP & Format preparation, Implementation of GSOPs, Change Controls, Training, Risk Assessments, Gap assessments and Audit related activities. Support for engineering new projects, training management and other activities as assigned.

Job Responsibilities

1. Execute all engineering operation as per established ARPL standards and procedures.
2. Ensure and maintain safe work place at ARPL all time in coordination with EHS personnel.
3. Perform all work in accordance with established regulatory, compliance and safety requirements.
4. Initiation and handling of Deviations, CAPA, Effectiveness checks, Non-CAPA follow up tasks, SME records, temporary changes and Change Controls.
5. Perform quality investigation with right first time.
6. Follow up with the respective cross functional teams for on time completion of deviations/CCR/CAPA/QMS activities.
7. Coordinate for audits and preparation of audits responses.
8. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements.
9. Execute with Quality Assurance department for preparation and implementation of engineering department SOPs/Formats and other engineering documents.
10. Preparation and review of SOP’s relevant to engineering including its periodic revision, compliance and trainings.
11. Initiation, assessment and closure of change controls related to engineering.
12. Conduct impact analysis of proposed corrective & preventative actions. Discusses findings with impacted departments and prepare recommendations to implement.
13. Assists in quality Investigations Initiations, and CAPA’s associated to engineering.
14. Support for GMP/Regulatory audit and preparation of audit compliance report & ensure closure of audit observations.
15. Preparation and review of risk assessments.
16. Review of all engineering documents such as protocols, Maintenance work order / notification, calibration report (But not limited to).
17. Preparation of Gap assessments for assessing the engineering practices with the procedures.
18. Attend training session related to cGMP, regulatory latest technical and industrial developments related to engineering projects.
19. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
20. 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.
21. All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum Bachelor’s degree in Engineering
• Knowledge, Skills and Abilities
  • Good knowledge of Quality Management system, exposure to audits, Risk Assessment, etc.,
  • Should have good interpersonal and communicational skills.
  • Works effectively towards achieving the engineering compliance.
  • Hands on experience in Track wise application, SAP and MS Office etc.,
  • Shall have exposure to any of the regulatory audits like USFDA, MHRA, TGA & HC.
• Experience
  • Minimum 8 years of experience in a Pharmaceutical industry