Analyst in Quality Control (QC)📣 إعلان

About the Role

Pharma Pharmaceutical Industries & Biological Products is seeking an Analyst in Quality Control (QC) for a full-time position in Riyadh Region, Riyadh. This role is crucial for ensuring pharmaceutical products meet stringent quality, safety, and efficacy standards throughout the manufacturing process.

Role Overview

The QC Analyst is responsible for rigorous testing of pharmaceutical products, from raw materials to finished goods, including packaging materials. The position operates within current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP) frameworks to maintain regulatory compliance. This involves validating analytical procedures and ensuring adherence to quality standards at every stage of production.

Key Responsibilities

• Implementing standard operating procedures (SOPs) and safety precautions.
• Adhering to cGMP and Good Laboratory Practice (GLP) standards.
• Performing calibration, maintenance, and qualification of laboratory instruments and equipment.
• Conducting routine and non-routine analysis of raw materials, water, in-process samples, finished products, and stability samples.
• Executing physical, chemical, and microbiological testing, including techniques such as HPLC, GC, and spectroscopy.
• Performing release and stability testing for drug substances and drug products.
• Executing cleaning verification and analytical method validation.
• Performing sampling of water, raw materials, and packaging materials.
• Affixing quarantine and release labels and notifying supervisors of out-of-specification results.
• Completing detailed documentation, including data capture forms and logbooks.
• Interpreting test results against specifications to determine batch disposition.
• Generating compliance records such as deviations, Out of Specifications (OOS), Change Controls, and Corrective and Preventive Actions (CAPAs).
• Investigating OOS results and conducting root cause analysis.
• Writing and revising SOPs, Standard Test Methods, and Work Instructions.
• Troubleshooting instrument problems.
• Supporting laboratory inspection readiness and participating in audits.
• Serving as a technical liaison between QC and other departments.
• Training junior analysts on laboratory procedures.
• Facilitating technology transfer of methods from Analytical R&D to QC.

Qualifications and Experience

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 2-5 years of experience in pharmaceutical QC or a related laboratory environment.

Technical and Regulatory Skills

• Knowledge of analytical techniques including HPLC, GC, Dissolution, and spectroscopy.
• Proficiency in aseptic techniques for biologics.
• Understanding of cGMP, ICH guidelines, and FDA/EMA regulations.

Work Environment

This is a full-time position located in Riyadh Region, Riyadh. The role operates within a regulated pharmaceutical manufacturing environment, requiring strict adherence to quality and documentation practices.