Quality Control Officer

Overview

The Quality Control Officer is responsible for supporting quality control activities at Cipla's Saudi Arabia site in Riyadh. This role ensures the timely completion of QC laboratory qualifications, validations, instrumentation procurement, and area qualifications while maintaining compliance with current Good Manufacturing Practices (cGMP), data integrity, and relevant global regulatory standards.

Key Responsibilities

• Manage QC lab instrument and equipment procurement processes, including document preparation such as URS, SIA, PRA, and GxP protocols.
• Perform qualification and validation of laboratory instruments and equipment based on established SOPs and protocols.
• Conduct QC area qualifications and temperature mapping activities within defined timelines.
• Execute daily QC laboratory tasks according to priorities set by the Section Head, including calibration scheduling and maintain annual maintenance contracts for instruments and equipment.
• Prepare analytical reports, chromatographic data, justifications, and maintain laboratory documentation ensuring right-first-time execution and prompt resolution of QC activities.
• Ensure adherence to cGMP, data integrity principles (including ALCOA++ compliance), and all regulatory requirements from SFDA, EU GMP, MHRA, WHO, and PIC/S.
• Maintain inspection readiness for regulatory audits, support audit responses, and perform scientific troubleshooting for out-of-specification (OOS), out-of-trend (OOT) results, deviations, impurity evaluations, and regulatory queries.
• Provide training to analysts on various analytical techniques such as HPLC/UPLC, GC, UV, FTIR, dissolution testing, and advanced analyses.
• Promote a culture of compliance, scientific decision-making, and safety within the Quality Control section.
• Support new product introductions, technology transfers, and stability studies tailored to Saudi regulatory project requirements.

Qualifications and Experience

• Master’s degree in Analytical Chemistry or Pharmaceutical Chemistry preferred.
• 8 to 10 years of professional experience in pharmaceutical quality control, including expertise in non-routine analytical activities, method validation and verification, method transfer, computer system validation (CSV), instrument calibration/validation/qualification, stability support, and routine analytical testing.

Skills and Knowledge

• Advanced knowledge of analytical techniques such as HPLC, GC, UV, FTIR, dissolution testing, impurity profiling, forced degradation studies, and stability evaluation.
• Strong familiarity with cGMP guidelines, data integrity principles (ALCOA++), and regulatory standards from SFDA, EU GMP, MHRA, WHO, PIC/S, and ICH.
• Excellent skills in analytical troubleshooting, RCA (root cause analysis), risk assessment, CAPA management, and the investigation of OOS/OOT results.
• Competence in supporting technology transfers, new product introductions, and audit preparedness for regulated markets with a focus on Saudi Arabia.