Senior QC & Validation Specialist – Pharma

Cipla; Riyadh; On-site; SAR 180,000 - 280,000; Full time

Job summary

Cipla Saudi Site seeks an experienced Quality Control professional to oversee QC activities, instrument qualification, and regulatory readiness across cGMP-compliant operations.

You will provide analytical troubleshooting for OOS/OOT, support technology transfer, and ensure ALCOA++ data integrity while preparing SOPs, protocols, and qualification reports for calibration and validation of HPLC, GC, UV, FTIR, and dissolution methods.

Qualifications

• MSc preferred in Analytical Chemistry or Pharmaceutical Chemistry.
• 8-10 years of pharmaceutical QC experience including non-routine analytical activities.
• Experience in method validation/verification, method transfer, CSV, instrument calibrations/validations/qualifications, stability support and routine analytical.
• Strong expertise in HPLC, GC, UV, FTIR, dissolution and related analyses.
• Knowledge of cGMP, ALCOA++, data integrity, SFDA, EU GMP, MHRA, WHO, PIC/S and ICH expectations.
• Strong analytical troubleshooting, CSV, OOS/OOT investigation, RCA, risk assessment and CAPA management capability.
• Ability to support new product introduction, technology transfer and regulatory audit responses for Saudi project requirements.

Responsibilities

• Prepare documents (URS, SIA, PRA & GxP) for procurement of new instrument/Equipment in QC laboratory.
• Qualification of instrument/equipment received in laboratory as per SOP/protocols.
• QC area qualification, Temperature mappings and adherence to timelines.
• Executions of allocated work from the Section Head.
• Prioritize QC activities like schedules calibrations /AMC’s for all the Instruments and Equipment’s.
• Prepare protocols, reports, chromatographic data, analytical justifications and laboratory documentation.
• Ensure right-first-time execution and timely closure of assigned QC activities.
• 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.
• Train analyst in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.
• Promote compliance culture, safety and scientific decision-making within the section.

Skills

HPLC

GC

UV

FTIR

Dissolution

Impurity profiling

Forced degradation

Stability studies

OOS/OOT investigation

Data integrity

cGMP compliance

Analytical troubleshooting

CSV

CAPA management

Education

M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry

Tools

HPLC systems

GC systems

UV-Vis spectrophotometer

FTIR spectrometer

Job description

Cipla Saudi Site seeks an experienced Quality Control professional to oversee QC activities, instrument qualification, and regulatory readiness across cGMP-compliant operations.

You will provide analytical troubleshooting for OOS/OOT, support technology transfer, and ensure ALCOA++ data integrity while preparing SOPs, protocols, and qualification reports for calibration and validation of HPLC, GC, UV, FTIR, and dissolution methods.