Quality Officer Engineering (f/m/d)

For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 0031 (0)20 7503 675.
Please note: Agency acquisition to this vacancy is not appreciated.  

Job responsibilities:

Enhancing the training and qualification status of the department:

• Development and optimization of the training matrix in the Engineering & Maintenance Department, anticipating on future needs and industry trends;
• Organizing for additional training on specific quality topics as needed;
• Monitoring the training status of the people in the department, addressing deficiencies to colleagues while looking for solutions, and escalating issues to the management as needed.
   

Coordinating and facilitating handling of quality processes within the department:

• Ensuring that deviations, CAPAs, changes and action items, and other quality records within the department are closed with the right result and within due date;
• Defining and continuously improving KPIs on quality records, escalating issues as needed, and defining and following up on a long-term quality strategy for the department;
• From a compliance point of view ensuring that department SOPs and Working Instructions are followed, and address follow-up measures as necessary;
• First point of contact internally and externally, for compliance related matters, and interfacing with QA and Quality Officers within other departments.
   

Auditing and Follow-up:

• Coordinator on behalf of the department during internal and external audits;
• Identifying gaps and mitigation plans based on observations and required future certifications.
   

Process Optimization and Continuous Improvement:

• Evaluating and challenging current working methods and processes and initiating / implementing proposals for improvement to enhance compliance and to lean up as appropriate;
• nterfacing with, and joining other Continuous Improvement initiatives to ensure maximum impact, both in the department and across the entire organization.

Qualifications required:

Higher technical education level in Applied Sciences, preferably in a (bio-) engineering field of expertise:

• Application knowledge of cGMP standards, PDA guides, ISPE Baseline Guides and Good Practice Guides for facilities, utilities, and equipment;
• Affinity for engineering and technical installations and documentation;
• Project Management skills to direct (temporary) teams as needed for implementations or mitigation plans;
• You reside in and are eligible to work in The Netherlands (valid work permit).