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For a major player in the global pharmaceutical industry, we are looking for a lab equipment validation support.
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.
Interested? Send your resume to email@example.com
This role is ideal for someone who is eager to develop towards a validation engineer within the pharmaceutical sector.
Responsibilities: - End to end qualification of lab equipment validation - Purchase of lab equipment: set up and write requirement specification documents, contact vendors, evaluate vendors, set up RFC’s (request for capital) according the departmental budget plan. - Validation of lab equipment: need to be able to set up and write a validation protocol, to analyze the validation results, provide conclusion and write validation report. Devices: spectrophotometers, balances, incubators, FTIR, … - 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
Education: Master degree in chemistry/sciences/pharmaceutics or equivalent by experience.
Work experience: - A minimum of 1 year experience with equipment validation. - Must: general knowledge of analytical instruments and validation technics - Experience in the creation of validation protocols, SOP’s, and preparation of validation reports. - Knowledge of Pharmacopeias (USP, Ph. Eur., JP) - Working knowledge of cGMP requirements.
Skills: - 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. - Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint.
Language skills: Good knowledge of Dutch and English language
what do we offer?
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - representation costs - training, ...