The function of Quality Specialist Operations is situated within the QA department that is responsible for the execution of the operational QA tasks related to a specific production, packaging or QC department in the production site.
You end up in a culture where ownership is an essential characteristic of every colleague. We want to excel today but also think about tomorrow and respond proactively to that. At the company we strongly believe in teamwork. In order to realize your work, we need each other, we help each other, challenge each other and share knowledge. "High quality" is the common thread in everything we do.
The function of Quality Specialist Operations ensures that all products meet internal and external quality standards and are produced according to the current company standards and legal requirements.
This function reports to the Quality Team Leader Operations.
'As Quality Specialist Operations you are responsible for the treatment of quality deviations and the daily support of a specific production, packaging or QC department.'
The following tasks fall under your authority:
• The evaluation of quality incidents and root cause investigations, corrective and preventive actions, and evaluation of the effectiveness of the preventive actions to prevent recurring deviations.
• The timely application of the escalation procedure to the Quality Team Leader Operations and senior management.
• Close cooperation with the Production, Packaging or QC department (including attendance at daily meetings) and with supporting departments (Product Support, Production Support, ...) to achieve the required quality and standards, as well as proactively improvement within Production, Packaging or QC.
• First point of contact for quality in general within your area. General representative of QA in the Operations Team.
• Close cooperation with QP Product Specialists and Supply Chain Management to ensure that deviations can be completed in time so that batches can be released to the market in time.
• Support of audits (preparation and illustration deviations).
• You have followed a university scientific education, preferably Pharmacy. Being certified as a Qualified Person is an added value.
• Work experience in an aseptic production environment and / or experience with the treatment of quality incidents of medicines / vaccines is an added value.
• You have good knowledge and understanding of cGMP.
• You have good facilitating abilities and you are a real team player.
• You use a pragmatic approach and you are driven to find solutions and book results.
• You have strong "technical writing and documentation skills" (Dutch and English).
• You are customer-oriented and know how to influence your stakeholders.
• Communicative you are strong and you know how to motivate your colleagues at different levels and you know to inspire (negotiate, assertive, convincing, diplomatic ...), both in Dutch and in English (verbally and in writing).
• You can organize yourself in an environment with varying priorities (good time management and prioritization).