Vacature Qualified Person
IDB Radio Pharmacy BV / IDB Holland BV, part of the AAA group is a manufacturer / distributor of radiopharmaceuticals for the benefit of Nuclear Medicine. These products are used both diagnostically and therapeutically in hospitals. IDB exports these products every week all over the world and has in recent years a significant growth.
To support our team we are looking for full time (p 40 week consultation.)
Independent supervision, without any interference of third persons, of the business processes of IDB Radiopharmacy, related to the drug manufacturing license. With respect to the quality of the medicinal products, assurance of compliance to the Dutch Medicines Law and other applicable regulations.
Together with the Head of Production maintaining an effective implementation, monitoring and maintenance of a GMP-compliant quality system.
Responsibilities of the Qualified Person:
The safeguarding of the quality of the medicinal products which have been manufactured by IDB Radiopharmacy in according to module 3 of ASMF (EU and US pharmaceutical standard) and MA. Safeguarding of the compliance with the GMP requirements within the organization based on the activities as described in the Quality Manual
Tasks of the Qualified Person:
- Design and implementation of a GMP – compliant quality system within IDB Radiopharmacy
- Auditing of contract manufacturers
- Assessment and release of manufactured medicinal products
- Release of incoming goods
- Maintenance of the IDB Radiopharmacy Quality Manual including internal audits
- Coordination of recall operations
- Complaint handling of customers
- Assessment and processing of deviations and CAPA’s
- Maintaining professional contacts with the Health Care Inspectorate
- Providing support regarding pharmaceutical issues to clients and employees
- Training of employees with respect to GMP
- Release of goods placed in quarantine
- self inspection program
- CAPA plan
- Support regulatory, corporate and customer audits of the site. Manage any inspection from regulatory competent authority (i.e. preparation, follow up)
- apply corporate guidelines
- set up a system of continuous improvement of quality (for example KPI, monitoring of IPC)
- perform annual quality review
- Assure the validation of manufacturing and analytic procedures
- Provide support to QA on an ‘ad hoc’ basis to assist in carrying out key QA responsibilities- including the provision of QA support to manage and escalate critical compliance issues through site QMS processes
Requirements for the job of the Qualified Person:
- Qualified as QP conform EU Directive 2001/83/EC
- Strong communication skills and fluent in Dutch, English
- Strong affinity with, and awareness of, quality issues
- Customer orientation and flexible working attitude.
- Team spirit
- Experience with sterile product will be a plus
- Min of 2 years of experience as QP
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