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Clean Room Operations Manager

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Job Summary

This role is responsible for implementing and executing operating guidelines for the cleanroom facility. The ideal candidate will have a strong understanding of technical operations, be able to manage demand, and arrange supply of all cleanroom requirements.

The person in this role will act as a Single Point of Contact (SPOC) for all operational activities related to labs and activities. This position will enable the smooth functioning of all labs and improve existing systems and processes to make them more efficient and compliant.

Key Responsibilities:

  1. Manage day-to-day site operations for all labs.
  2. Supervise and direct on-site instrument and equipment calibration and qualification.
  3. Generate and review GMP documentation such as Standard Operating Procedures, non-conformance reports, deviations, CAPA, cleaning records, temperature monitoring, and updates to the reporting manager.
  4. Verification of all annexures generated by lab technicians like cleaning record, temperature monitoring.
  5. Liaise between internal stakeholders and vendors for calibration/ AMC/ breakdown, and maintenance of instruments.
  6. Work with Quality & Compliance to ensure all-time audit readiness from a Lab & MFG perspective.
  7. Improve operational management systems, processes, and best practices.
  8. Prepare PRs for all instrument AMC and utility vendors.
  9. Coordinate with utility vendors for timely delivery of materials like liquid nitrogen, gas cylinders.
  10. Record and dispose of biomedical waste.
  11. Perform routine stock checks to maintain levels of critical stock consumables, restock gowning garments, and critical consumables in the clean area as required.
  12. Supervise lab technicians in their day-to-day activities.
  13. Provide training and mentoring to ensure good understanding of tasks allocated to lab technicians.
  14. Drive R&D Lab & Equipment procurement, maintenance & management.
  15. Support R&D sample management and act as SPOC for clinical samples received for R&D purposes.
  16. Support R&D procurement activities to consolidate orders to enable cost savings.