TQ Pharma is looking to hire “Method Development and Validation Analyst” with the following details:
Role summary: Handle the responsibility of performing testing and inspection of raw materials, stability samples, environmental samples, in-process and finished products within the laboratory, and auditing of corresponding documentation in compliance with internal SOP’s and applicable regulatory requirements, in addition to the responsibility of performing duties required in the application and continuous improvement of the company’s quality system. Duties and responsibilities: - Write and revise SOP’s in accordance with applicable regulations. - Perform and document raw material, in-process, and final release testing utilizing, but not limited to, HPLC, GC, Spectrophotometer, and IR. - Analyze results from routine environmental monitoring of the stability sample. - Perform data analysis of test results, and review data for compliance to SOPs and specifications. - Maintain laboratory supplies inventory. - Prepare assay reagents in accordance with applicable SOPs. - Perform laboratory maintenance and cleaning activities. - Participate in test method development and validations. - Ensuring good housekeeping within the unit. - Investigate and troubleshoot assay problems. - Organize RD/AR laboratory data and statistics for Departmental and Management review meetings - Participate in OOS investigations. - Identifying nonconformance cases and bringing them to the attention of the unit supervisor. - Safeguarding equipment from damage and unauthorized use. Qualifications: - Bachelor degree in Pharmacy, Chemistry, Medical Labs, Biology, or Chemical Engineering. - (3-5) years of experience in the field, 1 year in a similar position. - Good Knowledge in GLP. - Good knowledge in industrial systems. - Good management, communication and negotiation skills. - Excellent English language, other languages are plus. Interested candidates are kindly requested to submit their CV to
Hr@tqpharma.com
