Section Head – Quality Control

About the role

Lead the Quality Control (QC) section at Cipla’s Saudi site, overseeing laboratory qualifications, instrument procurement, and ensuring compliance with cGMP, SFDA and global regulatory standards. Provide scientific troubleshooting for OOS/OOT results, deviations and regulatory responses while building capability of analysts for new product introductions.

Key responsibilities

• Prepare URS, SIA, PRA & GxP documents for new QC instruments and ensure their qualification/validation per SOPs.
• Manage QC area qualification, temperature mapping and maintain inspection readiness for SFDA, EU GMP, MHRA, WHO and PIC/S audits.
• Plan and prioritize calibration, maintenance (AMC) schedules for all instruments and equipment.
• Review and approve analytical protocols, reports, chromatographic data and ensure right‑first‑time execution.
• Lead scientific investigations of atypical results, laboratory incidents and deviations, defining CAPA and verifying effectiveness.
• Develop and train analysts/team leaders on HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical techniques.

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, transfer, CSV, instrument qualifications and stability support.

Required skills

• Hands‑on expertise with HPLC, UPLC, GC, UV spectroscopy, FTIR and dissolution testing.
• Method validation, verification, transfer and CSV (Computer System Validation).
• Instrument qualification and qualification of laboratory areas.
• Strong knowledge of cGMP, data integrity, ALCOA+ principles and regulatory compliance (SFDA, EU GMP, WHO).
• Root‑cause analysis (RCA) and CAPA development for analytical investigations.