Leading Cleanroom Operations Specialist

18 hours ago

Bengaluru, Karnataka, India beBeeCleanroom Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title: Cleanroom Operations Manager

As a Cleanroom Operations Manager, you will be responsible for implementing and executing operating guidelines for the cleanroom facility. The ideal candidate should be able to manage technical operations by anticipating demand and arranging the supply of all cleanroom requirements.

Key Responsibilities:
  • Managing day-to-day site operations for all the labs
  • Supervising and directing on-site instrument and equipment calibration and qualification
  • Generating and reviewing GMP documentation such as Standard Operating Procedures, non-conformance reports, deviations, CAPA, cleaning records, temperature monitoring, and updates to the reporting manager
  • Verifying all annexures generated by the lab technicians like cleaning record, temperature monitoring
  • Liaising between internal stakeholders and vendors for calibration/ AMC/ breakdown, and maintenance of instruments
  • Working with Quality & Compliance to ensure all-time Audit readiness from a Lab & MFG perspective
  • Improving operational management systems, processes, and best practices
  • Creating PRs for all the instrument AMC and utility vendors
  • Coordinating with utility vendors for the timely delivery of materials like liquid nitrogen, gas cylinders
  • Recording and disposing of Biomedical waste
  • Performing routine stock checks to maintain levels of critical stock consumables, restocking gowning garments, and critical consumables in the clean area as required
  • Supervising lab technicians in their day-to-day activities
  • Providing training and mentoring to ensure a good understanding of the tasks allocated to the lab technician
  • Driving R&D Lab & Equipment procurement, maintenance & management
  • Supporting R&D sample management and acting as a SPOC for clinical samples received for R&D purposes
  • Supporting R&D procurement activities to consolidate orders to enable cost savings
Required Skills and Qualifications:
  • Understanding of IQ/OQ/PQ for instruments and documentations
  • GMP documentation
  • Clean room practices
  • Operations in the ERP system (SAP)
  • Material inspection

Soft skills: Basic IT skills, expert with MS Office (Excel, Word), good communication skills, team player & Collaborative, resourceful & Quality commitment, detail-oriented & Strategic thinker, enthusiastic & Committed.

Qualifications: Minimum Bachelor's degree in Science, eight+ years of related experience in relevant areas of lab operation and clean room area in pharmaceutical, working effectively and collaboratively across departments and functions. Prior experience working with GMP systems.

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