Periode: Project basis
Our client is a leading project management and engineering company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide full service engineering for their clients including project and program management, procurement, design, construction management, health and safety management, commissioning, qualification and start-up on numerous projects across a range of market sectors.
They have a very strong yet straight forward management structure which ensures there is a clear line of command and easy access to key decision makers. This structure also allows for regular and open engagement across all their operations, departments etc. ensuring we share resources, knowledge and learnings easily allowing their clients benefit by accessing the best and most suitable skill sets for their assignments.
The QA Auditor is responsible for providing advice, support and approval during:
- equipment installation, qualification and validation
- root cause investigation and corrective and preventive actions.
In addition the QA Auditor reviews and approves standard production documentation and protocols and acts as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.
- Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures;
- acts as a subject matter expert for GMP compliance during project;
- root cause investigations, change control procedures and improvement activities;
- approves final protocols and reports;
- ensures correct administration and documentation of data in accordance with guidelines and local procedures;
- acts as a mentor and coach for QA officer lvl 1.
- Higher education degree (HBO/university or equivalent);
- at least 5 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry;
- demonstrated experience in investigations, change control, validation and/or audits;
- extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and exceptional situations;
- knowledge of pharmaceutical manufacturing processes;
- business proficient knowledge of Dutch and English language is mandatory;
- strong organizational skills and ability to manage multi tasks at one time;
- ability to make decisions in a highly complex environment that balance business needs, quality and compliance risk;
- ability to provide direction and establish goals for individual staff/project members and work groups (planning/prioritizing/goal setting);
- resilience – ability to manage diversity and conflicting viewpoints at senior levels.