R&D Methodology & Validation

Employer:	Orchidia Pharmaceutical Industries
Job Title:	R&D Methodology & Validation
Location:	Cairo, Egypt
Job Type:	Full Time Employee
Category:	Other
Description:	Translate business goals into research objectives, plans, and deliverables. Correlating the results of the performed trials and experiments and recommending changes in method of analysis & procedures so that optimal parameters can be achieved. Reporting, documenting and summarizing the results of experimental trials and other data into a format that allow easy review by superiors. Follow up & control work flow to achieve objectives of validation with subordinates Follow up objectives and co-operate with subordinate to achieve them Development of methods for analysis of new drug products through literature, survey and methodological techniques. Validation of analytical methods to ensure its suitability for its intended use. Ensure of transferring method with all procedures and precautions from R&D to Q.C and solve any problems appear during analysis. Prepare & review validation files that are submitted to the Registration department for local and Export and cover all requirements. Reviews professional journals, scientific papers& updated pharmacopeia to keep abreast of changes in processing methods and legal and regulatory affairs which could impact company’s products or processes. Perform methodology and method validation of trial batches prepared in R&D laboratory. Organize methodology meeting with Q.C to discuss all OOS or any deviation in analysis of products. Preparation of SOPs related to work done in the R&D department. Review and control all documents related to Methodology and analytical method validation. supervise on entering specifications of finish products on ERP Supervise on Handling and controlling of reference and working standards used in analysis. Maintain and ensure of implementation of safety requirements Ensure of implementation of GLP requirements Update method of analysis to comply with export requirement (CTD form) Update method of analysis to match with new technique of analysis and implementation of impurity Participate in cleaning committee and prepare method cover they needs to apply cleaning validation
Qualifications:	Bachelor’s degree a must, in Pharmaceutical science or a related discipline. Four to Five years of technical experience in analytical method and training preferably in the pharmaceutical industry. Scientific, technical background in pharmaceutical as well as cosmetics products is beneficial. Using an advanced knowledge of research methodology and techniques. Excellent English, verbal / written communication. Ability to communicate well and work through others. Excellent computer skills. Self Motivating. Creative. Good problem solving skills. Good communications skills. Good self management skills. Capable of working in a team environment.
Education:	Bachelor's degree / higher diploma
Experience:	Min: 1 Max: 3
Salary:	Unspecified
Contact:	Apply

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