Ga je binnenkort alleen wonen? Spannend! Nu kan je je eigen stek inrichten zoals jij wil, zelf bepalen wat je gaat koken en je dag helemaal zelf indelen. Top! Maar alleen gaan wonen brengt natuurli...
QA GMP Specialist
Consultys, the market reference in pharmaceutical and biotech consulting
Consultys, a national and international partner, has more than 360 employees working on major projects for the world’s leading pharmaceutical and biotech groups.
Driven by a company philosophy based on human values, proximity and professional excellence, Consultys offers the resources to help every individual to achieve optimal performance.
CONSULTYS is a global engineering and services consulting company exclusively dedicated to the bio industry. Since 2005 we handle major international laboratories’ technical projects.
Our 260 consultants are currently working on innovative projects in engineering, production, quality (QA, QC, validation), R&D and regulatory affairs across Belgium, Switzerland and France.
CONSULTYS is well-known for its values such as respect, transparency and performance. We truly believe in proximity management so that our consultants can develop technical competencies in a pleasant environment. Our wide range of biotech competences allows us to provide our expertise in all stages of pharmaceutical industry lifecycle.
Consultys Benelux is looking for QA GMP specialist (F/M) to reinforce his Consulting team. As a consultant, you will be assigned to a client project being responsible for QA activities related to the QA Systems, QA documentation and/or QA oversight of internal and external partners. You will establish adequate ways of working in alignment with cGMP, the client procedures and international/local regulations (ICH, GMP, FDA/EMA Guidelines)
Depending on the project, you may be responsible for:
• Working closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP
• Providing strong assistance in managing customer complaints and third-party claims
• Authoring and revising standard operating procedures, policies and records
• Controlling the process of out of scope, deviation, change control, annual product and maintain appropriate quality metrics
• Working closely with others to determine root cause and potential preventative/corrective actions
• Ensure timely closure of investigations
• Monitoring QA process and manage communication and reporting according to a defined frequency
• Supporting employee training to diffuse new regulations and policies
• Providing oversight on software/equipments/processes validation according to QA standards
• Collaborating on QA aspects with other departments (Production, QA, RA, PV, R&D, IT)
• Master or Engineer degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas
• At least one year’s experience in Quality Assurance/Control in a regulated environment preferred (Biopharma, Cosmetic, Agri-food)
• Knowledge of GMP
• You are meticulous with attention to detail
• You have a systematic, methodical and organized approach
• Good problem-solving skills and the ability to handle sudden emergencies and changes
• Strong writing and oral communication skills
• Ability to manage time effectively and meet deadlines and requirements accordingly.
• Customer oriented
• The diplomacy and tact define you
• You are able to remain focused on the rules
• You are familiar with the documentation
• You are a partner working with others department to improve processes
• Ability to implement changes and identify mechanisms that will reduce, mitigate or eliminate regulatory risk
We bieden aan
Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, Join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.
Artikels die voor jou interessant kunnen zijn
6 zaken waar je moet aan denken als je alleen gaat wonen
- Engels: zeer goed
- Frans: zeer goed