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Quality Assurance
3 meses atrás
Kelly Science and Clinical is currently recruiting a QA / PV Officer, to work in the Lisbon area, with a Pharmaceutical and Medical Devices company.
Responsibilities as a QA / PV Officer include, but are not limited to:
- Collaborates with Regional and Global teams to support local planning and execution for Market Access procedures;
- Participates in Product/Project team work, delivering as per agreed timelines and needs under the scope of the Quality Assurance activity;
- Monitors the external regulatory environment to help inform/advise in the regulatory decision making;
- Ensures/supports regulatory product compliance (e.g. agency commitments, ...);
- Prepares and reviews quality related documentation;
- Participates in investigations, close deviations and propose CAPAs;
- Proposes, participates and assesses changes to established procedures or processes;
- Prepares and approves Quality Risk Assessments.
The ideal candidate will have:- Master's degree (pharmaceutical area);
- QA and PV experience related to the country(ies);
- GDP Knowledge and experience;
- QMS knowledge;
- Regulatory knowledge and experience within EU.
If you are keen to apply for this role, or want to know more about it, please submit your CV through our portal.
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- Master's degree (pharmaceutical area);