Senior QC Analyst

Department: Quality Control (QC)
Job Level: Senior Pharmacist / Specialist
Reports To: QC Lead
Location: Alexandria, Egypt

Job Purpose

The Senior QC Analyst is responsible for performing and reviewing chemical analysis of pharmaceutical raw materials, in-process samples, finished products, and stability samples using advanced analytical instruments and techniques. The role ensures accurate, reliable, and timely analytical results in compliance with GMP, GLP, pharmacopoeial requirements, approved specifications, and company procedures.

Key Responsibilities

• Perform chemical and instrumental analysis of pharmaceutical raw materials, in-process materials, finished products, and stability samples according to approved specifications and analytical methods.

• Operate, maintain, and troubleshoot analytical instruments, particularly HPLC, as well as other laboratory instruments such as GC, UV-Vis, FTIR, and dissolution testers.

• Perform HPLC analysis, including sample preparation, system suitability testing, sequence setup, chromatographic data review, and result calculation.

• Ensure analytical testing is performed accurately and in accordance with approved SOPs, analytical methods, specifications, and pharmacopoeial standards.

• Review analytical data, calculations, chromatograms, and laboratory records to ensure accuracy, completeness, and compliance.

• Investigate OOS (Out of Specification), OOT (Out of Trend), atypical results, and laboratory deviations in accordance with established procedures.

• Support analytical method validation, verification, transfer, and development activities when required.

• Perform routine calibration checks and basic troubleshooting of laboratory instruments and coordinate with relevant departments for major maintenance or technical issues.

• Prepare and maintain accurate analytical records, worksheets, logbooks, and electronic laboratory documentation.

• Ensure proper handling, labeling, storage, and disposal of samples, standards, reagents, and laboratory chemicals.

• Participate in stability studies and ensure testing is performed according to the approved stability protocols and schedules.

• Support investigations related to analytical results, deviations, CAPAs, and change controls.

• Ensure compliance with cGMP, GLP, data integrity principles, and applicable pharmacopoeial requirements.

• Participate in internal and external inspections and provide required QC documentation and technical support.

• Assist in training and mentoring junior QC analysts on analytical techniques, laboratory procedures, and instrument operation.

• Coordinate with other QC sections, Production, QA, and relevant departments to ensure timely completion of testing activities.

• Identify opportunities to improve laboratory processes, analytical efficiency, and data accuracy.

Key Technical Skills

• Strong hands-on experience with HPLC and chromatographic analysis.

• Good knowledge of GC, UV-Vis, FTIR, dissolution, and other pharmaceutical analytical instruments is an advantage.

• Strong understanding of pharmaceutical chemical analysis and analytical methodologies.

• Knowledge of USP, BP, Ph. Eur., and other relevant pharmacopoeial requirements.

• Knowledge of analytical method validation and verification.

• Familiarity with OOS/OOT investigations, deviations, CAPA, and change control.

• Good understanding of GMP, GLP, and Data Integrity requirements.

• Ability to interpret chromatograms and investigate analytical abnormalities.

• Good laboratory documentation and analytical calculation skills.

Requirements

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, or a relevant scientific discipline.

• Relevant experience in Quality Control within the pharmaceutical industry.

• Proven hands-on experience in chemical analysis and HPLC operation.

• Strong attention to detail and commitment to analytical accuracy.

• Good problem-solving and troubleshooting skills.

• Good communication and teamwork skills.

• Ability to work effectively under pressure and meet testing deadlines.

• Good command of written and spoken English.

• Willingness to work according to the company's required working schedule and shifts, when applicable.

Preferred Experience

Experience in one or more of the following areas is highly desirable:

• Pharmaceutical Raw Materials analysis

• Finished Product analysis

• Stability testing

• HPLC method validation / verification

• Analytical method transfer

• OOS/OOT investigations

• Handling pharmaceutical regulatory or GMP inspections

• Experience with computerized laboratory systems or LIMS/CDS is an advantage.