Section Head QC
Listed on 2026-10-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Lead the Quality Control section for the Cipla Saudi Site and ensure timely execution of QC Laboratory Qualifications/Validation activities, Procurement of instruments and Equipment's and area qualification.
Provide strong scientific and analytical troubleshooting support for OOS/OOT, atypical results, laboratory deviations, impurity evaluations and regulatory responses while maintaining cGMP, data integrity, SFDA and global regulatory compliance.
Build capability of analysts and team leaders to support new product introduction, technology transfer and inspection readiness for regulated markets.
Accountability Cluster- Preparation of required documents (URS, SIA, PRA & GxP) for procurement of new instrument/Equipment in QC laboratory.
- Ensuring that all the instrument/equipment received in laboratory are qualified /validated as per SOP/protocols.
- Ensuring the QC Area qualification, Temperature mappings are carried out and are adhering to timelines.
- Work allocations and executions
- Plan, prioritize QC Activities like schedules calibrations /AMC's for all the Instruments and Equipment's.
- Review and approve 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 analysts/team leaders in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.
- Drive RFT documentation, KPI monitoring, workload planning and continuous improvement.
- Promote compliance culture, safety and scientific decision-making within the section.
- Lead Atypical result, laboratory incident and deviation investigations using scientific RCA tools.
- Evaluate method, instrument, sample, analyst and system suitability related variables.
- Define CAPA and verify effectiveness to prevent recurrence.
M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry is preferred.
10-15 years of pharmaceutical QC experience, including at least 4-5 years in non-routine analytical activities, method validation/verification, transfer, CSV, Instrument validations/Qualifications, stability support and analytical investigations.
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