Validation Expert Analytical Lab

仕事内容

• Validation of analytical methods & method transfer: need to be able to set up and write a validation protocol, to analyze the validation results, provide conclusion and write validation report
• Cleaning Validation: Sample preparation, HPLC analysis, processing of HPLC data with Empower software
• Compendial review: Assess compendial changes, perform method verification, training of analysts
• Annual review (reduced testing program): Data analysis + reporting
• Response to internal & external enquiries
• Review data generated by other analysts of the team
• 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.
• Provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis
• Share successes with other departments during report out session with management
• Organize and lead method transfer project meetings, attend conference calls
• Attend daily communication
• Work according to applicable safety guidelines

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
  

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