Senior QA Expert ESO
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Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
#LI-HybridPrimary Location: Warsaw Poland
Other Locations: Mumbai India; Hyderabad India
Relocation Support: This role is based in Warsaw Poland. Novartis is unable to offer relocation support: please only apply if accessible.
Join Novartis in shaping the future of quality excellence!
As a Senior QA Expert ESO youll ensure that all Novartis products manufactured by external suppliers meet international GMP standards and regulatory requirements. Acting as the Single Point of Contact youll drive compliance foster strong partnerships and lead continuous improvement initiatives that make a real impact on patient safety and global quality standards.
Job Description
Key Responsibilities
- 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.
Essential Requirements
- Bachelors 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.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Benefits and rewards:
Read our handbook to learn about all the ways well help you thrive personally and professionally:
Required Experience:
Senior IC
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
