JOB DESCRIPTION QUALIFIED PERSON

Purpose of position:

Ensure that batches of medicinal products have been manufactured and checked in
compliance with the laws and applicable cGMP rules and guidances and in accordance with
the requirements of the marketing authorization
Participate and manage various problem-solving duties occurring during pharmaceutical
manufacturing, deciding on most appropriate plan for solution, and approving plan of action
Provide training to other employees by demonstration, repetition, modelling, large group
training, etc.
Control the correct working of the Pharmaceutical QMS

Some Key tasks:

Decide on batch disposition of materials and final finished product in line with Annex 16 to
the EU Guide to Good Manufacturing
Operate in accordance with the Quality Management System to fulfil the Batch Disposition
tasks
Participate in Change controls proposed through the Change control system
Review and approve investigation reports
Collaborate with cGMP improvement activities
Act as one of the responsible pharmacists of the Company
Oversee the quality system, evaluation and approval of Change requests, CAPA plans and
outcome of quality reviews
Advice and approval of internal deviation handling and CAPAs.

Requirements:

Fluent in Dutch and English

Master degree, industrial pharmacist.
Completed with relevant training and courses
3 years of experience in a QP role for pharmaceutical manufacturing
Active in depth knowledge on international cGMP guidelines and pharmaceutical regulations.
Knowledge on HACCP and food regulations
Knowledge on Healthcare regulations.
Knowledge on Medical Device regulations
Knowledge on filling weight regulations