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Areas of responsibilities are :
• 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 :
• 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.
• Compendial review: Assess compendial changes, perform method verification, training of analysts
• 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 Specific requirements (skills) or experience for the assignment?
Education + experience :
• Master's (preferably) or bachelor degree in chemistry/sciences/pharmaceutics or equivalent by experience.
• Experience in the creation of validation protocols, SOP's, and preparation of validation reports
• Knowledge of Pharmacopeias (USP, Ph. Eur., JP)
• Working knowledge of cGMP requirements.
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Must haves :
• A minimum of 2 years' experience in an Analytical Lab.
• Experience with HPLC (experience on Waters system)
• Experience in method validation
• Knowledge Empower Software
Personal skills :
• Good verbal and written communication skills.
• Ability to work precisely and accurately.
• Team player with ability to work independently and to work in global cross-functional project teams.
• Proactive attitude, taking initiative to help drive the projects forward.
• 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