Operational Excellence Specialist

2 days ago

Bengaluru, Karnataka, India beBeeTechnical Full time ₹ 20,00,000 - ₹ 25,00,000
Job Title: Technical Operations Specialist

 

  • Role Description:

This role involves implementing and executing operational guidelines for a cleanroom facility, managing technical operations by anticipating demand, arranging the supply of all cleanroom requirements, and maintaining standards for smooth operations. The ideal candidate will act as a single point of contact (SPOC) for all operational activities related to labs and activities, enabling the smooth functioning of all labs and improving existing systems and processes.

  • Key Responsibilities:
  • Managing day-to-day site operations for all 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 lab technicians, including cleaning records and temperature monitoring
  • Liaising with internal stakeholders and vendors for calibration, AMC, breakdown, and maintenance of instruments
  • Working with Quality & Compliance to ensure audit readiness from a Lab & MFG perspective
  • Improving operational management systems, processes, and best practices
  • Creating PRs for all instrument AMCs and utility vendors
  • Coordinating with utility vendors for timely delivery of materials like liquid nitrogen and 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 good understanding of tasks allocated to lab technicians
  • Driving R&D lab and equipment procurement, maintenance, and 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 for cost savings
  • Required Skills and Qualifications:
  • Understanding of IQ/OQ/PQ for instruments and documentations
  • GMP documentation
  • Clean room practices
  • Operations in ERP systems (SAP)
  • Material inspection
  • Benefits:

 

  • Competencies Required:
  • Soft skills, including basic IT skills, expertise 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 pharmaceuticals, working effectively and collaboratively across departments and functions, prior experience working with GMP systems
  • Working Conditions:
  • Full-time and onsite position
  • 9:00 AM to 6:00 PM general shift and 2:00 PM to 11:00 PM post-noon shift (rotational basis)
  • Occasional travel required for business needs

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