Senior QA Validation Specialist At Orchidia pharmaceutical
R&D – Methodology and Validation Senior Pharmacist At Orchidia Pharmaceuticals
Overall Purpose of the Job
Performing analysis activities testing of research and development, solving any problems encountered in all the developed methods of analysis, developing method of analysis and specifications for finished products, searching for methods of analysis of new products in different pharmacopeias and references.
Essential Tasks:
Participate in translating business goals into research and development objectives, plans, and deliverables.
Correlate the results of the performed trials and experiments and recommend changes in method of analysis and procedures so that optimal parameters can be achieved.
Report, document and summarize the results of experimental trials and other data into a format that allow easy review by superiors.
Follow up work flow to achieve objectives of validation with subordinates.
Develop methods for analysis of new drug products through literature, survey and methodological techniques.
Validate analytical methods to ensure its suitability for its intended use.
Ensure of transferring method with all procedures and precautions from research and development to quality control and solve any problems appear during analysis.
Prepare validation files that are submitted to the registration department for local and export and cover all requirements.
Reply to deficiency letters from the regulatory authorities.
Review professional journals, scientific papers and 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 research and development laboratory.
Participate in methodology meeting with quality control to discuss all OOS or any deviation in analysis of products.
Prepare and maintain SOPs related to work done in the research and development department and all documents related to methodology and analytical method validation.
Update specifications of finished products on ERP and research and development software.
Handle and control of reference and working standards used in analysis.
Update method of analysis to comply with export requirement (ECTD 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.
Work through, follow and adhere to safety instructions and requirements in research and development labs.
Work according to GLP, GMP and GDP rules.
Participate in the EHS activities. Via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
Skills
Bachelor’s degree in Pharmaceutical science.
From 3 to 5 years of technical experience in methodology and training preferably in the pharmaceutical industry.
Scientific, technical background in pharmaceuticals as well as cosmetics products is beneficial.
Using an advanced knowledge of research methodology and techniques.
Excellent English, verbal / written communication.
Excellent computer skills.
High creativity and innovation.
Capable of communicating and working in a team environment.
Education
Pharmaceutical Science