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Quality Assurance Officer, Prague

Czech Republic, Prague, Prague
Publikováno 2025-01-31
Vyprší 2025-03-03
ID #2578641692
Free
Quality Assurance Officer, Prague
Czech Republic, Prague, Prague,
Publikováno January 31, 2025

Popis

Job Description Role and Responsibilities The Quality Officer will support all audit activities within Prime Vigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with Prime Vigilance and procedures and global regulations.

The Quality Officer will perform all activities described, including but not limited to: Audit Support: Supports Prime Vigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by Prime Vigilance internal QA function Hosts onsite and remote audits Provides support for regulatory inspections of clients Assists in scheduling client requests for audits/inspection support Administrative support Supports Quality in the tracking of audit status and deliverables Metrics and Key Performance Indicators Supports Quality in the compilation and reporting of metrics and KPIs Collects and collates data from systems and sources Authors reports and summaries CAPA Support Activities Supports Quality in the tracking of Deviations and CAPAs Facilitates CAPA response and resolution Inputs data into the global audit CAPA tracker Other Supportive Responsibilities:  Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs Supports the Prime Vigilance Senior Leadership team as needed.

Supports other Quality activities as needed.

Qualifications University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with pharmaceutical industry experience.

Or equivalent pharmaceutical industry experience.

Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare Thorough understanding of the principles of Quality Assurance Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information Experience of participating in audits and inspections Excellent communication and facilitation skills within a global organisation Proactive and self-motivated Additional Information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   To succeed we must work together with a human first approach.

Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  We offer:  Training and career development opportunities internally   Strong emphasis on personal and professional growth  Friendly, supportive working environment  Opportunity to work with colleagues based all over the world, with English as the company language  Our core values are key to how we operate, and if you feel they resonate with you then Prime Vigilance could be a great company to join!   Quality  Integrity & Trust   Drive & Passion   Agility & Responsiveness   Belonging  Collaborative Partnerships   We look forward to welcoming your application. 

Podrobnosti o práci

Typ práce: Plný úvazek
Typ smlouvy: Trvalý
Typ platu: Měsíční
obsazení: Quality assurance officer

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