Job Title: Quality Assurance Officer
Location: Zagreb, Croatia
Job Type: Full-time
Department: PV QA
About the Company:
PrimeVigilance, part of Ergomed PLC, is a specialized pharmacovigilance service provider established in 2008. With a global presence in Europe, North America, and Asia, PrimeVigilance provides top-tier support to pharmaceutical and biotechnology partners across various therapy areas, including medical devices. The company is dedicated to continuous growth and delivering high-quality services. PrimeVigilance values its employees by offering excellent training, professional development opportunities, and fostering a healthy work-life balance to ensure satisfaction and success.
Job Responsibilities:
Audit Support:
Support PrimeVigilance functional teams during pre-audit, audit, and post-audit stages
Host onsite and remote audits
Provide support for regulatory inspections of clients
Assist with scheduling client requests for audits/inspection support
Administrative Support:
Track audit status and deliverables
Provide administrative support for Quality activities
Metrics and Key Performance Indicators (KPIs):
Assist in compiling and reporting metrics and KPIs
Collect and collate data from systems and sources
Author reports and summaries
CAPA Support Activities:
Track Deviations and CAPAs
Facilitate CAPA response and resolution
Input data into the global audit CAPA tracker
Document Preparation and Other Responsibilities:
Support the preparation of controlled documents (e.g., SOPs, OGs) by reviewing drafts
Provide support to the PrimeVigilance Senior Leadership team as needed
Assist with other Quality-related activities as required
Required Qualifications:
Education:
University degree in Biomedical Sciences, Natural Sciences, Health Sciences, Pharmacy, or equivalent scientific discipline
Master’s degree or equivalent pharmaceutical industry experience is preferred
Experience:
Previous experience in the pharmaceutical and/or regulated industry, preferably in Pharmaceuticals or Healthcare
Thorough understanding of Quality Assurance principles
Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information
Experience in participating in audits and inspections
Skills:
Excellent communication and facilitation skills within a global organization
Proactive, self-motivated, and detail-oriented
Advanced proficiency in English
Additional Information:
PrimeVigilance fosters a diverse, equitable, and inclusive workplace that welcomes people of all backgrounds, genders, and ages.
The company follows a human-first approach, recognizing that its people are the key to continued success and improving lives worldwide.
PrimeVigilance offers internal training, career development opportunities, and a supportive working environment with global colleagues.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
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