Quality Control Officer

Job Purpose:

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:

Project deliverables.

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.

Educational qualifications:

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

Relevant experience:

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.