Section Head QC

About the role

Lead the Quality Control section for the Cipla Saudi site, ensuring timely execution of QC laboratory qualifications, validation activities, and equipment procurement. Provide strong scientific and analytical troubleshooting support for out‑of‑specification results, atypical findings, laboratory deviations, impurity evaluations and regulatory responses while maintaining cGMP, data integrity, SFDA and global regulatory compliance.

Key responsibilities

• Prepare URS, SIA, PRA and GxP documents for new QC instrument procurement and ensure qualification/validation per SOPs.
• Oversee QC area qualification, temperature mapping and adherence to project timelines.
• Plan and prioritize calibration, maintenance and AMC schedules for all instruments and equipment.
• Review and approve protocols, analytical reports, chromatographic data and laboratory documentation.
• Maintain compliance with cGMP, data integrity, ALCOA++ principles and regulatory expectations.
• Ensure inspection readiness for SFDA, EU GMP, MHRA, WHO and PIC/S audits.
• Lead analytical investigations, atypical result and deviation investigations using scientific RCA tools.
• Define CAPA actions, verify effectiveness and prevent recurrence.
• Develop capability of analysts and team leaders through training in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.
• Drive continuous improvement, KPI monitoring and workload planning for the QC section.

Required profile

• M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry (preferred).
• 10‑15 years of pharmaceutical QC experience, including 4‑5 years in non‑routine analytical activities, method validation/verification, technology transfer, CSV, instrument qualifications, stability support and analytical investigations.

Required skills

• HPLC / UPLC
• GC
• UV spectroscopy
• FTIR
• Dissolution testing
• Method validation
• Analytical investigations
• ALCOA+ compliance
• Laboratory documentation
• cGMP
• CAPA management
• Audit trail review
• Stability support
• Data integrity
• GxP knowledge
• CSV (Computer System Validation)