Validation Lab. Specialist

About the Position

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.

We are currently seeking a Validation Lab Specialist to join our team in Cairo, Egypt. In this role, you will be responsible for performing and reviewing all validation laboratory activities, ensuring compliance with global guidelines and quality standards.

Responsibilities

• Perform and review all analytical chemical and physical testing related to validation activities, including analytical method validation procedures, testing process validation samples, and testing cleaning validation samples.
• Prepare and report all testing results to ensure global guidelines and quality standards.
• Perform, generate, and review analytical method and cleaning validation documentation, including 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, including evaluating methods against standards such as the International Council for Harmonization (ICH) guidelines and various pharmacopoeias.
• Modify and troubleshoot analytical testing methods during their execution whenever necessary, with approval from the Lab Manager and/or the Lab Section Head.
• Follow up on and control all documentation related to validation laboratory instruments, including 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.

Requirements

• Bachelor’s degree in pharmacy or chemistry.
• Minimum of 2 years of experience in a similar industry and experience using HPLC.
• Strong analytical skills.
• Detail-oriented.
• Excellent English language skills (speaking and writing).

We Offer

• Opportunity to join a dynamic organization where decisions are taken fast and you can actively participate in shaping our future.

About the Company

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.

If this sounds exciting, we would love to hear more about you!