Microbiologist

Job Purpose

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

Project deliverables.

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.

Educational qualifications:

M.Sc. in Microbiology is preferred.

Relevant experience:

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.