Pauwels Consulting
Pauwels Consulting, with head offices in Diegem and Ghent, is a fast-growing, independant and dynamic company with more than 100 employees. For over ten years Pauwels Consulting has been a loyal partner with expertise in IT, Engineering and Pharma for plenty of clients in Belgium, the Netherlands, Germany and France. In IT we offer global solutions with new technologies for application and web development, Business Intelligence and data warehouse. Our network and system engineers support our clients with our infrastructure services, helpdesk and support in different operating systems. In Engineering Pauwels Consulting is the number one partner for large (petro)chemical, industrial and production companies in Belgium and the Netherlands. We offer solutions for design, process, construction and supervision of specific projects. The consultants in our business unit Engineering Services can always be hired for solid support to industrial projects. Pauwels Consulting is also the perfect Pharma partner, not just for pharmaceutical and biotech companies, but also for their suppliers. Our consultants validate computer systems, processes, lab equipment and other specific applications. Our experts also provide on site quality control, audits and analysis, and GMP training and coaching and even product support. If so desired, we can set up projects from a to z (Special Projects). Pauwels Consulting's strength lies in our consultants. Pauwels' consultants are flexible and enthusiastic high potentials, and we are very happy to put our experience and expertise to work for the success of our clients.
QA OFFICER COMPLIANCE
Description de la fonction
• Participates in internal audits and inspections as well as in conducting follow-up to non-compliance issues.
• Audits/inspections may include cGLP, cGMP, cGCP and/or in-house compliance evaluations.
• Reads and interprets documentation for new and current compliance procedures and regulatory enforcement trends/actions. Participate in the preparation and review of procedures.
• Assists in solving compliance problems with other project disciplines.
• Participates in determining corporate quality and compliance policies.
• Completes all duties as per relevant SOP's.
• Investigates deviations/OOS/EOS/… ensuring all product issues are closed prior to system / area release.
• Completes analysis, identifies issues and provides recommendations for compliance improvements.
• Evaluates and signs off on documents related to his/her area of expertise
• Provides guidance to less experience staff.
• Assists supervisor and manager during regulatory inspections
• Record review (validation documentation, protocols/reports for IQ, OQ and PQ)
• Application of the policy on the welfare of the employees and the environment corresponding the attained education and instructions by i.a. the correct application of work equipment and personal protective equipment, the reporting of incidents and non-compliances and the assistance in the identification of risks and preventive measures
Profil
• Bachelor's or Master's degree in Chemistry or Bio-Chemistry, Pharmaceutical and/or Bio-techniques or Industrial Engineer Chemistry. (or equivalent by experience)
• More than 3 years of relevant experience in a Quality function
• Good working knowledge of cGLP/cGMP/cGCP in a regulated environment.
• Good working knowledge of manufacturing/QC/TY/PL/F&E processes and the application of quality principals.
• Excellent accuracy and attention to detail.
• Good interpersonal skills.
• Should be able to work with and try to resolve interpersonal relationship problems within the departmental organization.
• Good presentation skills.
• Good writing skills
• Should be able to write documents intended for internal audiences
• Working knowledge of computer packages.
• General knowledge of quality systems.
• Good understanding and application of pragmatic GMP principals to quality systems
Offre
- A position with responsability within a leading international company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation, including a range of fringe benefits