As a quality assurance consultant you work with customers in the pharmaceutical industry to ensure quality on projects or during routine operations. You review quality critical documents and records, and you ensure the quality management system of the client is correctly followed. Depending on your background and your level of experience you also give advise on regulatory requirements, facilitate risk assessments and investigations, you assist during regulatory inspections, give training and might even be asked to conduct internal or supplier audits on behalf of our customers.
As validation consultant you execute validation projects on location at clients in the pharmaceutical industry. This can be production equipment validation, lab equipment validation but it can also concern the validation of facilities and utilities, processes and computer systems. Depending on your background and interests you will be active in one or more of these areas.
Our customers count on your expertise related to regulatory requirements and your insights to manage project risks. You are responsible to write documents such as validation plans, FMEA risk assessments, URS, IQ, OQ and PQ. Also you execute or follow-up on the execution of validation test runs.
As CSV consultant you execute computer validation projects on location at the customer or from our offices. You are involved with the analysis of user requirements, testing and implementation of new software solutions. Our customers in the pharmaceutical industry count on your expertise related to regulatory requirements and your insights to manage project risks.
As Project Engineer, you are responsible for determining the technical and user requirements, the selection, tendering and/or design of pharmaceutical equipment, facilities, utilities or automation. You ensure the follow-up during the different phases (design, construction, commissioning, etc.), as well as the proper and timely delivery of the project. You manage the change control process, the definition and execution of the validation strategy, Commissioning & Qualification.
You manage and keep the oversight of involved contractor companies, and ensure that their work is done on time, with the required quality and safety on site. You ensure the handover and support at start of operations.
Consultant QC Analytical
As a QC Analytical Method Validation Consultant you support and execute routine and project related analytical method validation activities. You perform Root Cause Analysis and support the implementation of preventive and corrective actions. You support the development, improvement and/or transfer of QC methods and assist in the writting of reports. You support the organization during internal and external audits.
Data integrity consultant
As data integrity consultant you execute assessments on systems to evaluate their compliance with the applicable regulations or internal requirements of the pharmaceutical client. You identify areas of non-compliance or improvement, you draw up action plans and are involved in the execution of projects to improve the overall compliance in the company.
You have a scientific degree and want to become a true multipotential in the pharmaceutical industry? Or you have relevant experience but want to broaden your horizon? Then this job posting is for you.