Operational Specialist

7 days ago

Bengaluru, Karnataka, India beBeeOperational Full time ₹ 12,00,000 - ₹ 25,00,000
Job Title:

Operational Specialist

Key Responsibilities:
  1. Manage site operations for labs, ensuring compliance with GMP guidelines.
  2. Oversee instrument calibration and qualification, maintaining quality standards.
  3. Create and review GMP documentation, including SOPs, non-conformance reports, and deviation records.
  4. Verify annexures generated by lab technicians, such as cleaning records and temperature monitoring.
  5. Liaise between stakeholders and vendors for calibration, maintenance, and repair of instruments.
  6. Work with Quality & Compliance to ensure audit readiness from a lab perspective.
  7. Improve operational management systems and processes.
  8. Coordinate procurement activities for instruments and utilities.
  9. Supervise lab technicians in their daily tasks.
  10. Provide training and mentoring to ensure understanding of allocated tasks.
  11. Drive R&D Lab equipment procurement, maintenance, and management.
  12. Support R&D sample management and act as SPOC for clinical samples received.
  13. Collaborate on R&D procurement activities for cost savings.
Competencies Required:
  1. IQ/OQ/PQ for instruments and documentation.
  2. GMP documentation skills.
  3. Clean room practices expertise.
  4. ERP system operations (SAP).
  5. Material inspection knowledge.
Qualifications:
  1. Bachelor's degree in Science.
  2. Eight+ years of related experience in lab operations and clean room areas in pharmaceuticals.
  3. Effective collaboration across departments and functions.
  4. Prior experience working with GMP systems.

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