Validation Expert Analytical Lab
- Jefferson Wells
- Fixed-term, Independent, Full-time
Validation Expert Analytical Lab
Our partners innovate to bring treatments to their patients that significantly improve their lives.?Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.
Currently we are looking for a Validation Expert within the analytical lab of our pharmaceutical partner. As a validation expert you will be responsible for the validation of analytical methods and method transfer.
What are your responsibilities?
- Need to be able to set up and write a validation protocol
- Analyze the validation results, provide conclusions and write validation reports
- Cleaning validation
- Sample preparation, HPLC analysis, processing of HPLC data with Empower software
- Compendial review: assess compendial changes, perform method verification and training of analysts
- Annual review (reduced testing program)
- Data analysis and reporting
- Response to internal and 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 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
Who are you?
- 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, SOP’s, 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
- Strong computer skills including experience using Microsoft Word, Excel, PowerPoint
- Good knowledge of Dutch and English language: 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
- Ability to effectively manage workload and prioritize activities
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?
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- Professional bachelor (Higher Education Short Type)
- Company car
- 4 August
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