Quality Control Officer

About the role

The Quality Control Officer will support the Cipla Saudi site by ensuring timely execution of QC laboratory qualifications, instrument procurement, and area qualification. The role provides scientific and analytical troubleshooting for OOS/OOT events, atypical results, and regulatory responses while maintaining cGMP and data‑integrity standards.

Key responsibilities

• Prepare URS, SIA, PRA & GxP documents for new QC instruments and equipment.
• Qualify received instruments/equipment according to SOPs and protocols.
• Conduct QC area qualification and temperature mapping within defined timelines.
• Prioritize and schedule calibrations, AMC’s, and maintenance for all instruments.
• Prepare protocols, analytical reports, chromatographic data, and laboratory documentation.
• Ensure right‑first‑time execution, timely closure of activities, and compliance with cGMP, ALCOA++ and regulatory expectations.
• Maintain inspection readiness for SFDA, EU GMP, MHRA, WHO and PIC/S audits.
• Support regulatory and customer audits, providing analytical justification for deficiencies.
• Train analysts on HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical techniques.
• Promote a compliance culture, safety and scientific decision‑making within the QC section.

Required profile

• M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry (preferred).
• 8‑10 years of pharmaceutical QC experience, including non‑routine analytical work, method validation/verification, method transfer, CSV, instrument calibrations/validations/qualifications, stability support and routine analysis.

Required skills

• Strong expertise in HPLC, GC, UV, FTIR, dissolution analysis, impurity profiling, forced degradation and stability studies.
• In‑depth knowledge of cGMP, ALCOA++, data integrity, SFDA, EU GMP, MHRA, WHO, PIC/S and ICH expectations.
• Analytical troubleshooting, OOS/OOT investigation, root‑cause analysis, risk assessment and CAPA management.
• Ability to support new product introduction, technology transfer and regulatory audit responses for Saudi projects.