Quality Control Officer

Cipla; Riyadh; On-site; SAR 180,000 - 280,000; Full time

Job summary

Cipla Saudi Site seeks an experienced Quality Control professional to oversee QC activities, instrument qualification, and regulatory readiness across cGMP-compliant operations.

You will provide analytical troubleshooting for OOS/OOT, support technology transfer, and ensure ALCOA++ data integrity while preparing SOPs, protocols, and qualification reports for calibration and validation of HPLC, GC, UV, FTIR, and dissolution methods.

Qualifications

• MSc preferred in Analytical Chemistry or Pharmaceutical Chemistry.
• 8-10 years of pharmaceutical QC experience including non-routine analytical activities.
• Experience in method validation/verification, method transfer, CSV, instrument calibrations/validations/qualifications, stability support and routine analytical.
• Strong expertise in HPLC, GC, UV, FTIR, dissolution and related analyses.
• Knowledge of cGMP, ALCOA++, data integrity, SFDA, EU GMP, MHRA, WHO, PIC/S and ICH expectations.
• Strong analytical troubleshooting, CSV, OOS/OOT investigation, RCA, risk assessment and CAPA management capability.
• Ability to support new product introduction, technology transfer and regulatory audit responses for Saudi project requirements.

Responsibilities

• Prepare documents (URS, SIA, PRA & GxP) for procurement of new instrument/Equipment in QC laboratory.
• Qualification of instrument/equipment received in laboratory as per SOP/protocols.
• QC area qualification, Temperature mappings and adherence to timelines.
• Executions of allocated work from the Section Head.
• Prioritize QC activities like schedules calibrations /AMC’s for all the Instruments and Equipment’s.
• Prepare 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 analyst in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.
• Promote compliance culture, safety and scientific decision-making within the section.

Skills

HPLC

GC

UV

FTIR

Dissolution

Impurity profiling

Forced degradation

Stability studies

OOS/OOT investigation

Data integrity

cGMP compliance

Analytical troubleshooting

CSV

CAPA management

Education

M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry

Tools

HPLC systems

GC systems

UV-Vis spectrophotometer

FTIR spectrometer

Job description

Support Quality Control 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.

Support new product introduction, technology transfer and inspection readiness for regulated markets.

Major Activities / Tasks:

Preparation of required documents (URS, SIA, PRA & GxP) for procurement of new instrument/Equipment in QC laboratory.

Qualification of instrument/equipment received in laboratory as per SOP/protocols.

QC Area qualification, Temperature mappings are carried out and are adhering to timelines.

Executive QC operations

Executions of allocated work from the Section Head.

Prioritize QC Activities like schedules calibrations /AMC’s for all the Instruments and Equipment’s.

Prepare 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

Training and Laboratory excellence.

Train analyst in HPLC/UPLC, GC, UV, FTIR, dissolution and advanced analytical evaluation.

Promote compliance culture, safety and scientific decision-making within the section.

M.Sc. in Analytical Chemistry or Pharmaceutical Chemistry is preferred.

8-10 years of pharmaceutical QC experience, including experience in non-routine analytical activities, method validation/verification, Method transfer, CSV, Instrument Calibrations/validations/Qualifications, stability support and routine analytical.

Skills required:

Strong expertise in HPLC, GC, UV, FTIR, dissolution Analysis, impurity profiling, forced degradation, and stability studies.

knowledge of cGMP, ALCOA++, data integrity, SFDA, EU GMP, MHRA, WHO, PIC/S and ICH expectations.

Strong analytical troubleshooting, CSV, OOS/OOT investigation, RCA, risk assessment and CAPA management capability.

Ability to support new product introduction, technology transfer and regulatory audit responses for Saudi project requirements.