QC Senior Specialist - Microbiology/EM

Job Description Summary

-Highly skilled and experienced laboratory professional who contributes by performing Microbiological In-Process and release testing, investigational support, Raw material MET/BET testing, Environmental testing (EM), support method implementation studies, etc.

 

Job Description

Key Responsibilities:

• OOx/Deviation handling.
• CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of Microbiological release data / tests release, EM protocol/report preparation.
• Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Essential Requirements:

• 3-5years experience in Pharma/Manufacturing sector in Microbiological/EM laboratory
• Collaborating across boundaries.
• GMP environment/equivalent.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management