Validation Expert Analytical Lab

Verantwoordelijkheden

• As a Validation Expert Analytical Lab, you are responsible for ensuring the validation and transfer of analytical methods within the laboratory.
• You set up and write validation protocols, analyze validation results, provide conclusions, and write validation reports.
• You prepare samples, conduct HPLC analysis and process HPLC data using Empower software.
• You assess compendial changes, perform method verification and train analysts.
• You analyse data and report findings.
• You respond to internal and external inquiries related to validation and analytical methods.
• You review data generated by other analysts within the team to ensure accuracy and compliance.
• You develop and review departmental documentation, including lab data sheets, training materials, SOPs, change controls, deviations, and CAPA. 
• You provide analytical technical expertise in pharmacopeia tests, regulatory requirements, method changes and root cause investigations.
• You share key findings and successes with other departments during report-out sessions with management.
• You organize and lead method transfer project meetings and attend relevant conference calls.
• You actively participate in daily communication within the team and across departments.
• You ensure all activities comply with applicable safety guidelines and regulations.

Vereisten

• Master's degree in chemistry/sciences/pharmaceutics or equivalent by experience.
• A minimum of 5 years’ experience in an analytical lab / method transfer.
• Experience in the creation of validation protocols, SOP’s and preparation of validation reports.
• Experience with HPLC and knowledge of Pharmacopeias (USP, Ph. Eur., JP).
• Knowledge of cGMP requirements.
• Good verbal and written communication skills.
• Strong computer skills (Microsoft Word, Excel, PowerPoint). 
• Good knowledge of Dutch and English.