Microbiologist

Cipla; Riyadh; On-site; SAR 250,000 - 400,000; Full time

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

Support Microbiology for the Cipla Saudi Site and ensure timely execution of QC Microbiology Laboratory Qualifications/Validation activities, Procurement of instruments and Equipment’s and area qualification.

To ensure microbiological compliance and contamination control within the pharmaceutical manufacturing site through environmental monitoring, utility testing, microbiological analysis, and adherence to GMP requirements, ensuring product quality and patient safety and regulatory responses while maintaining cGMP, data integrity, SFDA and global regulatory compliance

Support new product introduction, technology transfer and inspection readiness for regulated markets

Accountability Cluster

Preparation of required documents (URS, SIA, PRA & GxP) for procurement of new instrument/Equipment for Microbiology laboratory.

Qualification of instrument/equipment received in Microbiology as per SOP/protocols.

Carry out Area qualifications, Temperature mappings in adherence to timelines.

Manage QC operations

Executions of allocated work from the Section Head.

Prioritize QC Activities like schedules calibrations /AMC’s for all the Equipment’s in Microbiology Laboratory.

Prepare protocols, reports, analytical justifications and laboratory documentation.

Ensure right-first-time execution and timely closure of assigned activities.

Ensure compliance with cGMP, Data integrity and regulatory expectations.

Ensure ALCOA++ compliance with raw data, electronic systems, audit trail review and laboratory records.

Maintain inspection readiness for SFDA, EU GMP, MHRA, WHO and PIC/S requirements.

Support regulatory audits, customer audits and deficiency responses with sound analytical justification.

Develop people’s Capability and Laboratory excellence.

Train analysts/team leaders in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.

Promote compliance culture, safety and scientific decision-making within the section.

M.Sc. in Microbiology is preferred.

8-10 years of pharmaceutical Microbiology experience should possess strong knowledge of microbiological testing techniques, method validation/verification, Method transfer, Environmental Monitoring, Instrument Calibrations/validations/Qualifications, stability support and routine analytical.