Job Title: Quality Assurance Officer
Location: Warsaw, Poland
Job Type: Full-time
Department: PV QA
About the Company:
PrimeVigilance, part of Ergomed PLC, is a leading pharmacovigilance service provider, established in 2008. The company has achieved significant global organic growth with staff across Europe, North America, and Asia, offering services in medical information, pharmacovigilance, regulatory affairs, and quality assurance. PrimeVigilance serves pharmaceutical and biotechnology partners, building long-term relationships and maintaining leadership in the industry. The company prioritizes employee well-being and work-life balance, fostering a healthy, high-quality client service environment.
Job Responsibilities:
Audit Support:
Provide support for pre-audit, audit, and post-audit stages
Host onsite and remote audits
Assist in regulatory inspections of clients
Schedule client audit/inspection support requests
Administrative and Metric Support:
Track audit status and deliverables
Compile and report 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 and Other Supportive Responsibilities:
Review draft documents (e.g., SOPs, OGs)
Support the Senior Leadership team as needed
Assist with other quality activities as required
Required Qualifications:
Education:
University degree in Biomedical Sciences, Natural Sciences, Health Sciences, Pharmacy, Nursing, or equivalent scientific discipline with pharmaceutical industry experience
Experience:
Previous experience in the pharmaceutical/regulated industry, particularly in a quality setting
Knowledge of Quality Assurance principles and relevant national regulations
Experience in audits and inspections
Skills:
Excellent communication and facilitation skills within a global organization
Proactive and self-motivated approach to work
Advanced knowledge of English
Additional Information:
PrimeVigilance values diversity, equity, and inclusion, creating an equal-opportunity, human-centric workplace.
The company offers training, career development, and growth opportunities, alongside a supportive, friendly working environment.
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