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.
Kom in contact met onze Consultant Indy
E-mail
i.oostrom@star-specialists.com
Telefoon
+32 472 09 83 33
WhatsApp
+32 472 09 83 33