Quality Officer (REF7052J)
- Siemensdamm, Berlin, Germany
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Quality Assurance Officer position supports all business areas, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Assurance Officer performs improvement activities through continuous monitoring and evaluation of the global quality management system to ensure ongoing maintenance.
Generate and prepare reports to communicate outcomes of quality activities.
Analyze and investigate, deviations and Quality Events to identify areas for improvement in the quality system.
Review, approve and communicate root cause and corrective action to stakeholders.
Develop, recommend, and monitor corrective and preventive actions. Tracks documentation, as necessary.
Collection, management, and analysis of data related to CAPAs, deviations and quality KPIs.
Record, track and trend audit findings and response times.
Support the Quality Manager during external client audits or regulatory inspections by creating reports, gathering documents and supplying requested data.
Perform effectiveness checks on deviations and Quality Events to determine efficacy of CAPAs.
In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits.
Supports and facilitates eQMS activities (i.e. Document Management, QA review and approvals, Change control assessments etc.)
Other duties as needed.
Minimum 2 years’ experience in Quality Assurance within the Pharmaceutical industry.
Deviation and CAPA handling experience
Data Management experience is a plus
Certifications an advantage including Quality Auditor, Quality Improvement Associate, Six Sigma
All candidates must be legally eligible to work in the Netherlands.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***