Section Head QC

Cipla

Riyadh

On-site

SAR 180,000 - 240,000

Full time

2 days ago
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Job summary

Cipla Saudi Site seeks a senior leader to head Quality Control, ensuring timely QC lab qualifications, validations, and instrument qualifications. The role drives analytical troubleshooting, regulatory compliance, and data integrity for SFDA and global standards.

You will develop analysts for new product introductions, tech transfer, and inspection readiness, while promoting a rigorous QC culture and continuous improvement.

Qualifications

  • MSc in Analytical Chemistry or Pharmaceutical Chemistry preferred.
  • 10–15 years in pharmaceutical QC with 4–5 years in non-routine analytical activities, method validation/verification, transfer, CSV, instrument validations/qualifications, stability support and analytical investigations.
  • Experience supporting regulatory audits and inspections.

Responsibilities

  • Lead the QC section for Cipla Saudi Site and ensure timely execution of QC Lab qualifications/validation activities.
  • Oversee procurement and qualification of instruments/equipment in the QC laboratory.
  • Ensure QC area qualification, temperature mappings, and adherence to timelines.
  • Plan, prioritize QC activities like calibrations/AMCs for all instruments and equipment.
  • Review and approve protocols, reports, chromatographic data, and analytical justifications.
  • Maintain ALCOA++ data integrity and readiness for SFDA/EU GMP/MHRA inspections.
  • Develop analysts and team leaders for new product introduction, tech transfer and inspection readiness.

Skills

Leadership
Analytical troubleshooting
Regulatory compliance
Data integrity
Training & development

Education

M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry

Tools

HPLC/UPLC
GC
UV
FTIR
Dissolution
CSV
Method validation

Job description

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.
Manage QC operations
  • 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 compliance with cGMP, Data integrity and regulatory expectations.
  • 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.
Develop people's Capability and Laboratory excellence.
  • 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 analytical investigations and scientific troubleshooting.
  • 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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