Quality Assurance (QARA) Administrator
Sunbury-Upon-Thames
Proactive Global is looking for a Quality Assurance Administrator (QARA) for a leading pharmaceutical products manufacturer based in Sunbury, TW16.
This is a permanent position.
Salary - £28-30K Per annum
Key Responsibilities
* Maintain and update the Quality Management System (QMS) in accordance with ISO 13485 and internal procedures.
* Administer document control processes, ensuring timely revision, approval, and distribution of controlled documents.
* Support CAPA, non conformity (NC), complaint handling, and change control processes.
* Assist with internal and external audits (Notified Bodies, FDA, suppliers).
* Ensure training records are accurate, complete, and up to date.
* Monitor calibration, equipment maintenance, and environmental controls as required.
Regulatory Affairs
* Assist in preparing documentation for the filing of regulatory submission.
* Manage registration activities for products in various markets (MHRA, EUDAMED, etc.).
* Support with keeping up to date with regulatory landscape changes by identifying and documenting gaps.
Qualifications and Experience
* Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, or related discipline).
* Experience in a regulated environment (preferably medical devices or pharmaceuticals).
* Understanding of ISO 13485, EU MDR, and/or FDA QSR requirements.
* Strong organisational and administrative skills.
* Excellent attention to detail and accuracy.
* Proficiency in MS Office (Word, Excel, Outlook, Teams).
Proactive Global is committed to equality in the workplace and is an equal opportunity employer.
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