- 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 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.
- 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
- 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.
- 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
Wat bieden wij?
Tormans invests in your future by offering appropriate training, personal guidance during the execution of your projects, advice and customized coaching.
Our projects are located at the most important (inter)national companies in various sectors, which means you will be introduced to the most modern techniques and the most diverse installations so that you can develop your knowledge and talent to the fullest
In addition to an open-ended contract with an attractive, tailor-made salary, we offer numerous extra-legal benefits, including meal vouchers, a daily allowance, company car with fuel card, hospitalisation insurance,..
At Tormans you can count on a professional, personal and honest no-nonsense approach.