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Job Ref. ID:  20332 
Job Title: Methodology Specialist
Division: Analytical Science & Technology (Quality)
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Methodology Specialist
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The major responsibility of the methodology specialist is to perform method validation and verification ‎activities. Routine job responsibilities include the writing, reviewing and executing of method validation ‎protocol and reports. The Specialist will coordinate and assist in investigative testing. ‎ The Specialist will demonstrate technical expertise in QC functions and will provide expert levels of technical ‎troubleshooting to the QC team. The Specialist will work in a detail-oriented, compliant manor in a fast-paced, ‎environment, on multiple concurrent projects. ‎ The Specialist is expected to adhere to tight deadlines with shifting priorities. The Specialist is expected to ‎perform review of generated data for conformance to approved quality standards and must report any ‎nonconformance or deviations to management in a timely manner for immediate required action. ‎ The Analytical Method Validation Specialist will report to Analytical Science & Technology Manager and ‎efficiently conduct all duties and responsibilities assigned and or delegated by the AS&T Manager.‎
Key responsibilities & Accountability: • Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UV, GC, ‎KF, FTIR, and A.AS in accordance with written SOPs • Provides technical project support, participating in protocol development and execution for test ‎method validation / verification and related activities • Provide expert level troubleshooting of laboratory equipment methods and process • Maintain lab work area and documentation in a neat and orderly fashion • Maintain data within a laboratory notebook in a legible, organized, and compliant manner, and ‎transcribes or enters data into necessary records in an accurate and timely manner • Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, ‎or other Deviation to Laboratory Management promptly for further investigation.‎ • Performs investigative testing or other functions to assist with laboratory investigations.‎ • Assists in execution of training and acts as a mentor to less-experienced analysts.‎ • Works in support of development projects and may require weekend, off-shift work, or overtime as ‎necessary to complete high priority work assignments • Interacts regularly with other departments including R&D, RA, and QA to ensure priorities are aligned ‎and products are on track.‎ • Reviews procedures and completes required documentation or updates as appropriate as part of ‎Periodic review process • Manages projects to improve Laboratory compliance and efficiency.‎ • Works on development of products, methods and projects to support R&D initiatives • Works with computers as well as laboratory software, or proprietary software as needed and ‎ensure proper Laboratory Management • Follow GLP, GMP and safety procedures and maintain hygienic conditions in lab.‎ • ‎Ensure and perform Qualification, Calibration of Quality control and AS&T Instruments and Evaluation ‎of column as per the Qualification, Calibration and Evaluation schedule • Fill the related SOP Attachment after performing the calibration and Label the Instrument ‎ • ‎Reads and follows Equipment & Quality SOP’s & follow safety during work and all plants.‎ • Must ensure technical review of previously generated data for Regulatory responses.‎ • Maintain and demonstrate a high level of personal and professional integrity and Report any ‎suspicious activity to laboratory management.‎ • Assists Laboratory Management on special projects and assignments • Additional responsibilities may be assigned by Laboratory Management as needed.‎ • Maintain all system inspection ready & presenting Validation reports to internal & external audits.‎ • Actively participate in continuous improvement initiatives.‎ • Conduct & deliver On – Job training wherever needed.
 Qualifications: 
   - Education • Bachelors ( 4 years) / Master’s Degree in Chemistry & Pharmacy
   - Experience: • Minimum 4-5 years of experience working in similar role in Pharmaceuticals industry. • Must possess strong project management experience
   - Training:
Key Competencies: • High on communication and collaboration , having an ability to manage multiple stakeholders at a ‎time • In terms of competency you are highly result oriented with strong sense of accountability & ‎ownership.‎ • Must be able to manage tasks and priorities and easily adapt to changing situations. ‎ • Good command in English (Communicating, writing and speaking)‎ • Good prioritizing skills and being able to make a just decision also in case of (time) pressure;‎ • Strong organizational skills and the ability to multitask • Demonstrated ability in working independently and as part of a team • Must be able to work in a cross-functional environment interacting with other internal departments ‎and external vendors • Ability to meet attendance standards. At times it may be necessary to work additional hours in order ‎to accomplish the required tasks to meet deadlines.‎ • Must have a teamwork attitude & ability to apply common sense understanding to carry out multi-‎step instructions • Deal with standardized situations with occasional variables • Ability to interpret data utilizing intermediate math operations; perform complicated analytical ‎calculations and statistical analysis • Ability to write or speak in the English language and communicate information effectively in one-on-‎one and in a group of employees within the organization.‎ • Must be highly organized, self-motivated to learn new things and implement them in building or updating ‎quality system for Pharmaceuticals.  
Technical Competencies: • Flexible learning abilities & Proficient in technical writing • Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.‎ • Must be able to communicate technical, scientific, and regulatory information, both written and ‎verbally • Ability to work in a detail-oriented manner • A Strong Background in Analytical Method Validation/Verification of In-House Method Development and ‎Pharmacopoeia Drug Products. • Major Expertise in Chromatography, Dissolution and spectroscopy. Trained on FDA 21 ‎CFR Part 210 and ‎‎211 regulations. ‎ • Knowledge in Chemistry and Pharmaceutical Drug Substances with a strong background in using ‎Analytical ‎Instruments like HPLC, GC, UV, Dissolution etc.., trouble-shooting and Maintenance ‎of ‎Chromatography and other analytical Instruments. ‎ • Proficient knowledge of USP and ICH guidelines of method validation and verification & Specification ‎setting.‎‎  
 

 
 

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