QA Officer (quality technical processes)

at  Ajinomoto BioPharma Services

FUNCTIE

• You take up the role as QA SME for the quality technical processes and practices at Wetteren and Balen
• Scope: utilities, pest control, change-over, cleaning of installations,…
• Ensure full and adequate control over all aspects (incl. change & deviation mgt)
• Manage the annual system review (ASR)
• Shape the activities across the BE sites as much as possible.
• You build a trusted relationships with internal stakeholders to enable optimal cooperation by:
• Actively listening to their concerns, demonstrating accountability and acting proactively
• Communication actively towards internal stakeholders about the status, possible change and impact.
• You work together with all involved departments (Production, Warehouse, QC, R&D, Maintenance, Engineering,…) to deliver in depth investigations in case of deviations and documentation of changes to the technical processes.
• You act as quality representative in company technical meetings.
• You organise the QA executed batch record review and perform the review of eBR during periods of high workload.
• You effectively support the product release in LIMS & SAP.
• You perform the QA review of production cleaning validation documentation & failures, incl. related CAPA mgt.
• You take up the role as QA OE champion, support the QA team through the OE journey and drive improvement projects within the QA team, including the roll out of reporting tools for adequate project follow up.
• You manage, draft & update procedures owned by QA, prepare training and user manuals and act as SuccessFactors TTE.
• You lead external project related audits: you accompany customers and authorities to make sure that they have a fair view on all technical process related quality documentation.

PROFIEL

• You are that enthusiastic person, showing affinity to technical processes and eager to become our quality expert subject matter.
• Your master degree is of course a good basis, but your experience is of equal value.
• Professional experience in quality, production or utilities is what we are looking for. On top having GMP experience makes you even a better candidate.
• You wear your analytical glasses and have your brains trained for being critical and expressing your arguments in a clear, logic way.
• You don’t mind communicating in English (and Dutch).
• Organizing and structuring your work is your second nature.
• Working independently: yes! Team work: yes!
• Operational excellence… is always on your mind.
• You are a real IT talent, playing with word, excel, sharepoint, outlook, BI reporting, … Even LIMS & QDS.
• You don’t hesitate to jump into your car to support your colleagues at the other BE site in case of specific project needs, gemba’s and audits.
• We must admit, pressure and deadlines will be around, but does not fear you at all.

Please refer the Job description for details