Senior Microbiological Quality Assurance Specialist
4 days ago
At Novartis, we are committed to helping people with diseases and their families. To achieve this goal, we require a highly skilled and experienced laboratory professional to join our team as a Senior Microbiological Quality Assurance Specialist.
About the Role- This is an exciting opportunity for a seasoned microbiologist to contribute to our quality assurance efforts by performing in-process and release testing, investigating support, raw material testing, environmental monitoring, and other related activities.
- CAPA definition: Ensure all activities are compliant with cGxP, including data integrity review and approval of microbiological release data/tests release.
- KPI trending: Maintain and analyze key performance indicators related to microbiological quality assurance.
- Ensure all activities are conducted in compliance with regulatory requirements, including preparation of EM protocols/reports.
As a Senior Microbiological Quality Assurance Specialist, you will be responsible for:
- Performing microbiological testing of materials, utilities, and personnel monitoring.
- Providing expert support for site qualification and validation activities.
- Maintaining and calibrating equipment, including plan preparation and supplier qualification.
- Trending and analysis of KPI/KQI metrics.
- Supporting sample planning and sampling execution.
- Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.
- 3-5 years of experience in the Pharma/Manufacturing sector in microbiological/EM laboratory roles.
- Degree in a relevant field such as biology, chemistry, or a related discipline.
- Excellent communication and analytical skills, with the ability to work effectively in a team environment.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and AccommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities.
Why Novartis?We believe that collaboration, support, and inspiration are essential to achieving breakthroughs that change patients' lives. If you are passionate about making a difference in the lives of others, we encourage you to join our team.
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