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Job Ref. ID:  50392 
Job Title: Associate - Analytical Technology Transfer
Division: Manufacturing Science & Technology (MS&T)
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Associate - Analytical Technology Transfer
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: Associate is responsible for Analytical Technology Transfer, method verification and validation activities. Routine job responsibilities include Testing the Trial production batch samples, writing, reviewing, and executing of Testing method evaluation protocol and reports. The Associate will coordinate and assist in investigate testing. He/she will demonstrate technical expertise in R&D and QC functions and will assist in troubleshooting to the QC teams. The Associate will work in a detail-oriented, compliant manor in a fast-paced, environment, on multiple concurrent projects. The Associate is expected to perform review of generated data for conformance to approved quality standards and must report any non-conformance or deviations to management in a timely manner for immediate required action.
Key responsibilities & Accountability: Responsible for Analysis of Pilot batches/Trial production batches of Various dosage forms. Responsible for analysis of RLD samples. Responsible for preparation of in-house technical documentation that support Technology Transfer projects (Analytical' Specs, STMs, Method Transfer protocols, etc.). Order laboratory reagents and accessories for the products testing and method transfer activities. Ability to critically analyse data using statistical tools and to compile technical reports. Knowledge of common and specific software in use in analytical labs. Interact and collaborate with cross-functional team that includes R&D, Quality control and operations. Perform method verification/validations for the technology transfer products whenever required. Liaising with the CRO for successful technology transfer of Analytical Methods. Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable local (GCC) and Global regulatory requirements.
 Qualifications: 
   - Education Bachelor's degree in Chemistry, Biochemistry or Pharmacy. Master degree is a definite advantage.
   - Experience: Minimum of 2-3 years of experience in Pharmaceutical Industry is required, with major expertise in chromatography and spectroscopy and Quality review in Analytical sections. Experience in review of data and manuscript of protocols and reports for analytical methods. Experience with developing, implementing, and commercializing methods for in-process testing, process characterization, release, and stability testing.
   - Training:
Key Competencies: Strong Technical Writing, Verbal Communication and presentation skills. Having an analytical mind with ability to think diversely, resolve problems with outstanding planning skill t manage and expedite complexities of procedures and regulations. Ability to critically analyse data using statistical tools and to compile technical reports. Develop, write, and review protocols and reports for the following batches: Product Characterization, Technology Transfer, Exhibit/Registration, and Validation. Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects. Ability to work under pressure, plan personal and team workload effectively and delegate.  
Technical Competencies: Knowledge of method development, validation, and method transfer. Knowledge of analytical methods/technologies as HPLC, A. As, GC, CE, ELISA, and/or other techniques. Knowledge with SOP writing, GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11). 
 

 
 

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