Senior Microbiology QC Lead – GMP Compliance & Tech Transfer

Cipla

Riyadh

On-site

SAR 250,000 - 400,000

Full time

3 days ago
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Job summary

Cipla Saudi Site seeks an experienced Microbiology professional to support QC operations, qualification activities, and regulatory readiness. You will oversee environmental monitoring, method validation, and instrument calibrations, ensuring data integrity and cGMP compliance across the site.

The role includes training analysts, supporting technology transfer, and preparing documentation for audits and inspections by SFDA and global regulators.

Qualifications

  • MSc in Microbiology preferred.
  • 8–10 years of pharmaceutical Microbiology experience.
  • Strong knowledge of microbiological testing techniques.
  • Experience with method validation/verification and method transfer.
  • Familiarity with cGMP, data integrity and regulatory compliance.
  • Experience with environmental monitoring and instrument calibrations/qualifications.

Responsibilities

  • Manage QC operations and prioritize calibration schedules for equipment.
  • Prepare URS, SIA, PRA & GxP documents for procurement of new instruments.
  • Carry out area qualifications and temperature mappings.
  • Ensure compliance with cGMP, data integrity and regulatory expectations.
  • Support regulatory audits and responses with analytical justification.
  • Develop people’s capability and laboratory excellence; train analysts in analytical techniques.
  • Maintain inspection readiness for SFDA, EU GMP, MHRA, WHO and PIC/S.
  • Support new product introduction and technology transfer.

Skills

Microbiology testing
Method validation
Environmental monitoring
Data integrity
Regulatory compliance
Instrument calibration

Education

MSc in Microbiology

Tools

HPLC/UPLC
GC
UV
FTIR
Dissolution

Job description

Cipla Saudi Site seeks an experienced Microbiology professional to support QC operations, qualification activities, and regulatory readiness. You will oversee environmental monitoring, method validation, and instrument calibrations, ensuring data integrity and cGMP compliance across the site.

The role includes training analysts, supporting technology transfer, and preparing documentation for audits and inspections by SFDA and global regulators.

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