Sterile Manufacturing Engineering Head

Key Responsibilities of the Engineering lead Profile.

Candidates only from Injectable Engineering Background :

1.New Project / Modification works from conceptual Layout to installation, commissioning and validation compilation

2. Resource development and assigning individual responsibilities

3. Lead Plant Maintenance Engineerring services to meet production demand in time

4. Effectively applies tools, methodology and intermediate review meetings

5. Facilitates cross function team for QMS

6. To review equipment's PM, URS, Risk mitigation and cGMP documents

7. Any other job assign by superiors as and when require

8. To provide all utilities with minimum down time and at maximum efficiency of equipment.

9. Co ordination and dealing with various government officials like Boiler inspector etc

10. Analysis and implementation of energy saving system like power, fuel, water etc.

11. To follow ‘Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

12. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed

13. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description

14. To ensure that, In case of any event of potential data breach, it shall be handled through SOP on ‘Handling of Potential Data Integrity Observation’.

15. To Participate and conduct self-inspection as an auditor in scheduled self-inspection.

16. To prepare self-inspection report and review self-inspection compliance report.

17. Candidate should have hands on maintenance experience in Sterile process machines.