Compliance Expert Responsibilities:
- Ensuring a strong GMP compliance level within the SCM department resulting in Permanent Inspection Readiness.
- Maintaining and improving the processes and related procedures to comply with the latest GMP standards. This includes writing & improving of various SOP’s and instructions (part of the Quality Management System).
- Ensuring that new regulations and guidelines (GMP) are effectively communicated and trained to all relevant personnel.
- Executing shop-floor visits to improve the compliance level by means of coaching and training in procedures, data integrity principles, root cause analyses etc.
- Preparing and guiding internal and external inspections and audits including the follow-up as a result of potential improvements.
- Coordinating Quality Notifications. Performing trend analysis to initiate & implement improvements.
- Coordinating root cause investigations in case on non-compliance and developing sustained preventive actions (fe update of procedures, training of personnel) in close cooperation with the business.
- Using Lean Six Sigma techniques in order to improve way of working
- Managing process changes in the global change management system for the manufacturing support center or service providers interfaces
- Coordinating complaints from the manufacturing departments or customers.
- Monitoring the operational GMP compliance status by KPI’s and coordinating specific actions at the department and site-broad level
- Participating in global or site-broad compliance improvement projects
- Connecting to other GMP experts within the site or other sites to harmonize & improve way of working.
- Maintaining and/or implementing a site-broad GMP standard.
- BSc or MSc in (Bio) Technology or equivalent qualification
- At least 3-5 years of relevant GMP experience in a biotech, pharmaceutical or chemical manufacturing organization
- Thorough knowledge of GMP and external regulations like FDA guidelines
- Demonstrated ability to manage improvement projects (Lean 6-sigma experience/ belt certificate is preferred)
- Pro-active attitude with an improvement mindset and strong analytical skills;
- Ability to influence and communicate with all levels of the organization from shop floor to senior management;
- Leads by example and must have excellent communication skills with shop-floor personnel.
- Experience with support of regulatory and corporate audits;
- Excellent writing and communication skills in Dutch and English.
- a young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- personal and professional development through guidance, education and knowledge sharing
- a competence development model focused on your personal ambitions
- an attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.