For one of our clients located in Geel, we are currently looking for a "Quality Contamination Control Engineer".
Job Description
Executing, coordinating and documenting inspections / investigations, as well as handling cGMP problems and nonconformities regarding contamination controls. Supporting and advising on the development and life cycle of business and production processes, equipment, utilities and facility, in accordance with cGMP standards, best practices and regulatory requirements. The goal of this position is to contribute to the reliability, stability, effectiveness and efficiency of business and production processes, as well as to ensure the optimization of the contamination control mindset throughout the organization.
Responsibilities
- Daily process support: both on demand and proactive. Providing advice, service and technical expertise within their own field. Guaranteeing the reliability (upon release) of installations, systems and / or (production) processes with regard to microbial control (contamination), as well as having an accurate insight into the effectiveness and efficiency of the processes.
- Process control monitoring the processes within the assigned sub-domain; adjust and escalate where necessary. Preventing deviations from the standard, resolving bottlenecks and identifying opportunities for improvement to meet the predetermined quality requirements.
- Quality assurance: Contamination Control Signaling, investigating, treating, following up and finalizing GMP and Contamination Control deviations and non-conformities, within the set timeframe with the necessary depth and in line with procedures, legal standards and quality requirements. Timely and efficient handling of every investigation, non-conformity and associated actions. Ensuring that product, processes, systems and installations meet the required quality standards and are also approved by all regulatory authorities, as well as prevent deviations from internal and external regulations
- Proactively following up relevant (market) developments in their own field and exchanging knowledge with internal and external customers. Building, stimulating and improving the quality contamination mindset throughout the organization. Be informed about recent developments and (help) translate them into accurate and relevant information for the organization. Contributing to the realization of the desired quality mindset.
- Process improvement (Co-) development, improvement and implementation of (new) (sub) processes, utilities, equipment, facility and methods, within the assigned sub-domain. Anticipate and resolve any structural problems. Contributing to a continuous increase in the quality, effectiveness and efficiency of used processes, utilities, equipment and facility.
- Building collaborative relationships and initiating consultation with experts across disciplines. Building and maintaining a professional network.
- Reporting and providing information periodically and at the request of the client, as well as reporting on the activities and results. Providing the relevant stakeholders with appropriate information in a timely manner, as well as the status and progress of the work. Contributing to the transfer of knowledge, traceability and correctness of collected data.
Requirements
- Bachelor or Master Degree
- Experience in environmental Monitoring (process of data gathering from the production, reporting samples and data taken in production, follow up of deviations and excursions) and qualification of HCAT systems
- Quickly deployable
- Experience in pharma, a plus is experience in microbiology
- Knowledge of NL and ENG
Benefits
- A balanced salary package based on your capabilities and experience.
- Full Time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16724
