Validation Expert Analytical Lab

Verantwoordelijkheden

• As a Validation Expert Analytical Lab you are responsible for the validation of analytical methods & method transfer: you need to be able to set up and write a validation protocol, to analyze the validation results, provide conclusion and write validation reports.
• You are responsible for Cleaning Validation: sample preparation, HPLC analysis, processing of HPLC data with Empower software.
• You are responsible for compendial review: Assess compendial changes, perform method verification, training of analysts.
• You ae responsible for the annual review (reduced testing program): data analysis + reporting
• You will respond to internal & external enquiries
• You will review data generated by other analysts of the team.
• You will develop and/or review departmental documentation including lab data sheets, training documentation, SOP's, change controls, deviations and CAPA (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines
• You will provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis
• You will share successes with other departments during report out session with management
• You will organize and lead method transfer project meetings, attend conference calls
• You will attend daily communication
• You will work according to applicable safety guidelines

Vereisten

• You have a Master's or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience. 
• You have a minimum of 2 years’ experience in an Analytical Lab. 
• You have experience in the creation of validation protocols, SOP’s, and preparation of validation reports. 
• You have experience with HPLC (experience on Waters system is a plus).
• You have knowledge of Pharmacopeias (USP, Ph. Eur., JP).
• You have working knowledge of cGMP requirements. 
• You have good verbal and written communication skills. 
• You have the ability to work precisely and accurately. 
• You are a team player with ability to work independently and to work in global cross-functional project teams. 
• You have a proactive attitude, taking initiative to help drive the projects forward. 
• You have strong organizational skills and demonstrated ability to manage projects to completion are highly desired. 
• You have strong demonstration of problem-solving skills. Open for innovation and proposal of new ideas. Have good creativity thinking skills. 
• You have the ability to understand and extract necessary information from technical documents. 
• You have the ability to effectively manage workload and prioritize activities. Ability to handle multiple tasks simultaneously and to meet critical milestones and goals. 
• You have strong computer skills, including experience using Microsoft Word, Excel, PowerPoint. 
• You have a good knowledge of Dutch and English language.