Quality Control Laboratory Analyst

Within the company, the main role of the Quality Control Laboratory Analyst is to perform analysis and report results.

The analyst may be assigned to any section such as raw material, finished product, stability, validation or microbiology, perform equipment calibration, documentation review, confirmatory analysis within investigations, and participate in internal quality systems including training. This must be done according to the rules of Good Manufacturing and Laboratory practices. This must be achieved through efficiency both in time and material resources, whilst consistently and continuously ensuring compliance with cGMP, cGLP, company procedures, EHS regulations as well as Pharmacopeial standards. 1. To carry out sampling, analysis of samples, and documentation of the analytical procedures performed according to cGLP and standards. 2. Personnel assigned to microbiological analysis are also to perform method suitability testing, sampling and testing of plant water, and maintaining the plant’s environmental monitoring programme. 3. To ensure GMP compliance as per local procedures, and EU Eudralex Volume 4 GMP guidelines. 4. To ensure compliance with established procedures relevant to the EHS management system in line with the organization’s policies, procedures, international standards and local and EU regulations in the daily operation of the Department. 5. To be responsible for maintaining a high standard of GLP, good housekeeping and hygiene in the laboratories. 6. To ensure that the equipment is calibrated before use. 7. To review the documentation performed before sign-off. 8. To ensure that all analysis and equipment usage are logged in appropriately according to cGLP and internal procedures. 9. To perform any necessary Analytical Documentation Review in accordance with cGLP in a timely manner. 10. To report immediately any OOS results, OOT results, abnormal results/observations, deviations from methods / procedures, and equipment breakages/malfunction to the QC Supervisor, QC Manager and/or Lab Support Coordinator. 11. To carry out the preliminary investigation and documentation review of analytical reports related to Lab Investigation Reports as required. 12. To ensure an adequate supply of consumables and chemicals as needed to maintain operation of the laboratory. 13. To write or update SOP`s, test methods and/or worksheets as required. 14. To assist fellow analysts with analysis problems and equipment troubleshooting. 15. To document any training received as per procedure. 16. To participate actively in case of an emergency situation requiring the activation of Business Continuity Plans. To keep the principles of Business Continuity at the forefront in the management of the department. 17. To perform any other additional duties that may arise from time to time.