Senior QA Expert
Kerr Dental
full-time
Posted on:
Location Type: Office
Location: Warsaw • 🇵🇱 Poland
Visit company websiteJob Level
Senior
About the role
- Act as Single Point of Contact for all quality-related activities at assigned external suppliers.
- Provide quality input and presence in technical meetings with external suppliers.
- Ensure supplier qualification and maintain valid Quality Agreements aligned with business needs.
- Monitor quality trends and drive continuous improvement through KPIs and performance assessments.
- Ensure site readiness for regulatory inspections and support during audits.
- Manage quality issues, including complaints, deviations, and out-of-specification results, ensuring timely resolution.
- Oversee change controls from initiation through implementation and closure.
- Support manufacturing process and analytical method transfers with robust QA oversight.
Requirements
- Bachelor’s degree or higher in Pharmacy, Biochemistry/Biotechnology, Chemistry, Microbiology, or a related science.
- Fluent in English, both spoken and written (minimum C1 level or equivalent certification).
- Minimum 8 years of experience in the pharmaceutical industry, including 5 years in sterile manufacturing.
- Expert knowledge of aseptic processes and biologics manufacturing; strong understanding of cGMP for EU and US markets.
- Advanced experience with FDA, EMA, and other Health Authorities; skilled in risk management and project management.
- Strong communication and negotiation skills; advanced decision-making abilities and basic leadership experience.
Benefits
- Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementsupplier qualificationKPI monitoringregulatory inspectionschange control managementanalytical method transferaseptic processesbiologics manufacturingcGMPrisk management
Soft skills
communication skillsnegotiation skillsdecision-makingleadership experience
Certifications
Bachelor’s degreeC1 level English certification