QC Senior Chemical Analyst📣 إعلان

About the Role

Jamjoom Pharma is seeking a QC Senior Chemical Analyst to join its team in Jeddah, Makkah, Saudi Arabia. This is a full-time position requiring 5-10 years of relevant experience. The role is critical for ensuring the quality and compliance of pharmaceutical products through rigorous chemical analysis.

Role Purpose

The QC Senior Chemical Analyst performs routine and non-routine chemical analyses on various materials, including raw materials, packaging materials, in-process samples, finished products, stability samples, and reference standards. This is conducted in strict adherence to approved specifications, pharmacopeial requirements, cGMP, GLP, and regulatory guidelines. The primary objective is to provide timely and accurate analytical support, uphold data integrity, ensure laboratory compliance, and contribute to the continuous improvement of Quality Control operations.

Key Responsibilities

• Perform chemical analysis of raw materials, in-process materials, finished products, stability samples, and cleaning validation samples according to approved specifications and analytical methods.
• Execute analytical testing while ensuring compliance with cGMP, GLP, ALCOA+, Data Integrity, and Good Documentation Practices (GDP).
• Operate, calibrate, maintain, verify, and troubleshoot laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Tester, Karl Fischer, pH Meter, and Analytical Balance.
• Prepare reagents, volumetric solutions, mobile phases, reference standards, and analytical solutions accurately.
• Perform analytical method validation, method verification, method transfer, and analytical troubleshooting.
• Review analytical data, chromatograms, calculations, and laboratory documentation before final submission.
• Participate in investigations related to OOS, OOT, Deviations, Laboratory Incidents, Change Control, and CAPA implementation.
• Maintain laboratory documentation, equipment logbooks, worksheets, and analytical records in accordance with GMP requirements.
• Ensure laboratory equipment remains qualified, calibrated, and fit for use.
• Maintain inventory and qualification status of laboratory chemicals, reagents, solvents, consumables, and reference standards.
• Support Regulatory Affairs, Quality Assurance, Production, Supply Chain, and regulatory authority requirements by providing analytical and technical support.
• Participate in internal audits, regulatory inspections, customer audits, and self-inspections.
• Follow laboratory safety procedures, environmental health and safety requirements, and proper use of PPE.
• Support continuous improvement initiatives within the Quality Control laboratory.
• Perform any additional Quality Control duties assigned by the supervisor.

Qualifications and Experience

• A minimum of 5 to 10 years of experience in chemical analysis within a Quality Control laboratory, preferably in the pharmaceutical industry.
• Demonstrated understanding and application of cGMP, GLP, ALCOA+, Data Integrity, and Good Documentation Practices (GDP).
• Proven ability to perform analytical method validation, verification, transfer, and troubleshooting.
• Experience participating in investigations (OOS, OOT, Deviations) and audits.

Essential Skills and Knowledge

• Proficiency in operating, calibrating, maintaining, and troubleshooting a range of laboratory instruments including HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Tester, Karl Fischer, pH Meter, and Analytical Balance.
• Strong knowledge of preparing reagents, volumetric solutions, mobile phases, reference standards, and analytical solutions.
• Meticulous attention to detail in maintaining laboratory documentation, equipment logbooks, worksheets, and analytical records.
• Adherence to laboratory safety procedures and environmental health and safety requirements.

Work Environment

This is a full-time position based in Jamjoom Pharma's facilities in Jeddah, Makkah, Saudi Arabia. The role operates within a Quality Control laboratory setting, requiring adherence to stringent regulatory and safety protocols.