Research Analyst 2 – Bioequivalence

Ras al-Khaimah
Wed Sep 15 2021 15:00:40 GMT+0000 (Coordinated Universal Time) save share

Job Title: Research Analyst 2 – Bioequivalence Division: Research & Development - Bioequivalence Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office) Job Type: Research Analyst 2 – Bioequivalence Employment Type: Full Time Employment (Un-limited Contract) Job Description: Purpose: The role of Analyst is to carry out comparative dissolution testing of trail, scaleup and commercial ‎batches. Operation and maintenance of ‎‏ ‏dissolution apparatus‏, ‏HPLC‏, ‏UV and other analytical ‎equipment‏. ‏Analyst to adhere with GLP‏, ‏GDP, cGMP principles and maintain them in an ‎effective manner. Maintains analytical data, laboratory records, reports and logbooks.‎ A research analyst 2 should be prepared to work in various sectors, such as marketing, business ‎operations, and finance. You should maintain highest standard of integrity & scientific ‎professionalism, and must be detail - oriented. ‎ Key responsibilities & Accountability: • Responsible to adhere with the GLP, GDP, cGMP principles and to maintain them in an ‎effective manner.‎ • Accountable to conduct comparative dissolution profile for trail batches, scaleup and ‎commercial batches against the respective reference products.‎ • Prepare Biowaiver dissolution studies including saturation solubility • Perform dissolution method development and validation as per guidance and SOP.‎ • Responsible for preparation of dissolution standard test methods, dissolution test protocol ‎and dissolution report.‎ • Maintain analytical data, laboratory records, reports and logbooks.‎ • Follow safety procedures and maintain hygienic conditions in lab • Responsible for operation and calibration of HPLC, UV, dissolution instruments and other ‎analytical equipment. ‎ • Proper handling of chemicals, solvents and analytical reagents ‎ • Coordinate with ARD team for dissolution profiling, analytical method development, ‎validation and report generation for newly developed formulations.‎ • Provide the technical support to other departments like QC, registration & subsidiaries • Work closely with product development teams and other cross functional teams right from ‎the product development initiation till the regulatory submission ‎ • Preform any other work assigned by Manager and support colleagues whenever ‎necessary.‎ Qualifications: - Education • ‎4 years Bachelor’s degree in in Pharmacy or related Sciences ‎ - Experience: • At least 3-5 years’ experience in new Product Development in a pharmaceutical industry. ‎ - Training: Key Competencies: • In terms of competency you are highly result oriented with strong sense of accountability ‎& ownership.‎ • High on process compliance with strong attention to details. ‎ • Must have a solution centric mind to understand issues and solve them within a stipulated ‎time frame, ability to understand new issues quickly and make scientific decisions. ‎ • Strong ability to communicate analytical results to scientific and non-scientific member • Strong communication, interpersonal, decision skills required • Motivated and highly organized professional and should be able to juggle competing ‎priorities.‎ • Ability to work under pressure, plan personal workload effectively and delegate.‎ • Able to develop strong, cooperative relationships with team members and other ‎colleagues Technical Competencies: • Strong Command in English is mandatory (communicating, writing and speaking). ‎ • Strong Knowledge of office management software like MS Office (MS Excel and MS Word, ‎specifically).‎ • Demonstrated knowledge of Generic product development, Dissolution studies and Invitro ‎release test (IVRT) for semi solids • Thorough proficiency of regulatory requirements of drugs as they apply to laboratory work.‎ • Demonstrated proficiency of computer systems for sample tracking, laboratory ‎equipment, raw data handling and storage.‎ • Understanding of safe laboratory practices and relevant HSE protocols.

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