Compliance Engineer GMP – Supply Chain Management - Netherlands
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Biotech production site consists of various production and supporting facilities for drug substance manufacturing.
- The SCM (Supply Chain Management) department is responsible for purchasing starting materials, production planning and distribution of drug substance to customers and managing external service providers (3PL) like storage and trucking companies.
- Also within SCM the Manufacturing Support Center resides that is responsible for warehousing, weighing and dispensing of starting materials in a clean room environment to support the manufacturing departments.
- Reporting into the Supply Chain Management Lead, the Compliance Engineer GMP will be responsible for ensuring compliance to internal and external GMP and GDP guidelines and regulations. You will be working closely together with the Manufacturing Support Center personnel, Third party logistic service providers and the Supply chain operations group.
- Since a new Manufacturing Support Center building is being developed the first focus of the position will be to support the compliance (QMS) implementation project next the normal operational activities.
Working as a Compliance Engineer, you will be responsible for:
- 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 and CAPA’s. Performing trend analysis to initiate & implement improvements;
- Coordinating root cause investigations in case on non-compliances 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 company 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.