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QA Officer Equipment Qualification and Laboratory equipment

Software Engineer

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QA Officer Equipment Qualification and Laboratory equipment Weert • Symeres Netherlands

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Gevraagd

Fulltime
HBO of hoger
Medior/Senior
Nederlands, Engels (talen)

Aanbod

Vast contract
Opleidingsbudget

Vacature in het kort

Weert

Join the dynamic Quality Management System team as a QA Officer Equipment Qualification. You'll play a vital role in ensuring compliance with cGMP regulations, corporate policies, and site procedures. Key responsibilities include providing support and guidance on equipment qualification, reviewing and approving documentation, and overseeing risk assessments and change controls. Enjoy a collaborative work environment while contributing to the manufacture of active pharmaceutical ingredients. Keep reading to explore the growth opportunities this position offers.

Over het bedrijf

Symeres Netherlands

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To increase our capacity, the Quality Management System (QMS) team at our Weert site is strengthening its team and is looking for an experienced and enthusiastic QA Officer Equipment Qualification. He/she effectively performs activities to ensure compliance with applicable current Good Manufacturing Practice (cGMP) regulations, corporate policies, and site standard operating procedures.

Key job responsibilities:

Provide support and guidance on qualification/calibration/maintenance of analytical equipment related to the cGMP manufacture of active pharmaceutical ingredients (APIs).
Review and approve qualification/calibration/maintenance documentation of analytical equipment.
Review and approve risk assessments related to analytical equipment qualification/calibration/maintenance.
Review and approve change controls, deviations, corrective and preventive actions (CAPAs) and effectiveness checks related to analytical equipment qualification/calibration/maintenance.
Support writing/revising standard operating procedures and work instructions related to analytical equipment qualification/calibration/maintenance.

Gevraagd

Qualifications:

At least HBO level or equivalent.
At least 3 years’ working experience in a QA function.
High level of initiative, flexibility, and problem solving.
Awareness of the relevant procedures for the function in terms of quality, safety, health, and environment.
Good written and oral communication skills (at least in Dutch and English).
Proficiency with Microsoft Office (Word, Excel, PowerPoint).
Working effectively with Information System team.
Working knowledge of cGMP guidelines and computer system validation (CSV) requirements in a pharmaceutical/regulated environment is preferred

Aanbod

Job offer
An exciting position in a dynamic organization with an attractive remuneration package and opportunities for learning and development.

Application
Please send an email with your CV and motivation to: via de button "Solliciteer nu" op deze pagina.. For substantive questions, please contact our Director Quality: via de button "Solliciteer nu" op deze pagina..

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