Laboratory Operations Specialist

6 hours ago

Bengaluru, Karnataka, India beBeeCleanroom Full time ₹ 20,00,000 - ₹ 25,00,000

**Job Summary:**

This role requires a professional with strong technical expertise to oversee the daily operations of our cleanroom facility. The ideal candidate will have a deep understanding of laboratory protocols, be able to manage resources effectively and arrange for the necessary supplies.

The person in this position will serve as a key liaison between internal stakeholders and vendors for calibration, maintenance and repair of instruments. This position will enable seamless communication and efficient functioning of all labs, improving existing systems and processes to make them more efficient and compliant.

Key Responsibilities:

  1. Manage day-to-day site operations for all labs ensuring compliance with GMP guidelines.
  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 with 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.

Competencies Required:

  1. Understand IQ/OQ/PQ for instruments and documentations.
  2. GMP documentation.
  3. Clean room practices.
  4. Operations in the ERP system (SAP).
  5. Material inspection.

Soft Skills:

  1. Basic IT skills, expert with MS Office (Excel, Word).
  2. Good communication skills.
  3. Team player & Collaborative.
  4. Resourceful & Quality commitment.
  5. Detail-oriented & Strategic thinker.
  6. Enthusiastic & Committed.

Qualifications:

  1. 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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