Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
As a Validation Lab Specialist, you will be responsible for performing and reviewing all validation laboratory activities. This includes test method validation, process validation analysis, and cleaning validation analysis. Your work will ensure that all validation practices comply with global guidelines and quality standards. The position will be located in our factory in El Obour City and reporting to the QC Lab Manager.
Your responsibilities:
- Perform and review all analytical chemical and physical testing related to validation activities. This includes conducting analytical method validation procedures, testing process validation samples, and testing cleaning validation samples. In addition, you will prepare and report all testing results to ensure global guidelines and quality standards.
- Perform, generate, and review analytical method and cleaning validation documentation. This includes developing and accessing protocols, preparing and reviewing reports, and ensuring accuracy and compliance in standard operating procedures (SOPs) and working instructions (WIs).
- Participate in root cause investigations of finished product failures.
- Verify chemical analysis methods received from the R&D department to ensure alignment with global regulatory guidelines. This includes evaluating methods against standards such as the International Council for Harmonization (ICH) guidelines and various pharmacopoeias, ensuring accuracy, reliability, and compliance before implementation in validation activities.
- Modify and troubleshoot analytical testing methods during their execution whenever necessary. Adjustments or corrective actions will be implemented only after obtaining approval from the Lab Manager and/or the Lab Section Head.
- Follow up on and control all documentation related to validation laboratory instruments. This includes, but is not limited to, maintaining and reviewing logbooks, calibration records, reagents, reference standards, and instrument qualification documents.
- Perform and review daily calibration for all lab equipment.
- Share in annual preparation for Quality control consumables.
- Share in preparation and review working standards used for chemical analysis of finished products.
- Record all analysis results.
Qualification and Experience:
- Bachelor’s degree of pharmacy or chemistry.
- Work experience: Min. of 2 years of experience with similar industry and experience using HPLC
- Analytical skills.
- Details oriented.
- Excellent English language (speaking and writing)
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
