Lab equipment validation HPLC/UPLC – Heist op den Berg

Introduction

We are looking for a lab equipment validation specialist for HPLC/UPLC

Function

– 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 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.

Requirements

Profile: 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 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

Offer

• Exciting projects in line with your knowledge and experience
• A team guaranteed to support you
• An employment contract with an interesting salary and interesting benefits but first and foremost:
• A unique HR policy aimed at following-up, training and coaching in order to stimulate your career.

Information

Hilde Vissers | Project Manager Sourcing
T: +32(0)15/79.47.94 | M: +32(0)472/982.663
Graaf van Egmontstraat 15/4 | Mechelen
Place de l’université 16 | Louvain-la-Neuve
E : [email protected] | W : www.qpeople.be

Application

Miriam Cobbaert | Business Development
T: +32(0)15/79.47.94 | M: +32(0)472/134.285
Graaf van Egmontstraat 15/4 | Mechelen
Place de l’université 16 | Louvain-la-Neuve
E : [email protected] | W : www.qpeople.be

Apply

Return