For a client in the province of Antwerp (East), we are looking for a Validation Expert Analytical Lab.
- Do you have two years experience in an analytical lab?
- Are you familiar with HPLC?
- Do you know the GMP regulations?
- Do you have a scientific degree?
Do you see a fit with your profile and these questions? Then this project might be just right for you!
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 inquiries
- 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
- Masters 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.
- Good verbal and written communication skills.
- Ability to work precisely and accurately.
- Team player with the ability to work independently and to work in global cross-functional project teams.
- Proactive attitude, taking the 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 to innovation and proposal of new ideas. Have good creative 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
Anneleen De Vos
015 21 11 04