Support of Lab Equipment Validation HPLC & UPLC

Areas of responsibilities are : 

• Qualification of lab equipment devices GC, HPLC & UPLC on waters 
• Need to be able to set up and write a validation protocol, to analyze the validation results, provide a conclusion and write validation report. 
• Develop and/or review departmental documentation including training, SOP's, change controls, deviations and CAPA’s (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines. 
• Provide analytical and microbiological technical expertise in pharmacopeia tests, regulatory requirements, changes, investigations and root cause analysis. 
• Share successes with other departments during report out sessions with management. 
• Organize and lead project meetings.  Attend daily communication. 
• Work according to applicable safety guidelines. 
• Response to internal & external enquiries 

Specific requirements (skills) or experience for the assignment: 

• Master degree in chemistry/sciences/pharmaceutics or equivalent by experience. 
• A minimum of 1-year experience with equipment validation. 
• Experience in the creation of validation protocols, SOP’s, and preparation of validation reports. 
• Must: Experience with HPLC & UPLC on Waters systems
• Knowledge of Empower (navigation system of HPLC devices of water) 
• 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 for 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 the Dutch and English language 

Extra info achtergrond: 
In departement 3 afdelingen: 
Calibratie: onderhoud+ productietesten (analytisch =dossering, oplossnelheid tablet + microbio testings)+ondersteuning leveranciers, Q doc schrijven, wijzigingen Q doc aanbrengen; 
Kwalificatie: verificatie

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