QC Coordinator

Summary 4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, execute business plans to meet the sales goals, develop effective professional business relationships with Healthcare Professionals will help the world understand what these medicines do, why they matter and how Novartis is striving to reimagine medicine. Patients are the inspiration behind everything we do. Looking for highly skilled and experienced laboratory professional who gives by performing analytical release testing, investigational support, research support, and stability testing About the Role

Major accountabilities:

• OOx/Deviation handling.
• CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
• Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification
• Review and approval of analytical tests (analytical release)
• Microbiological QC - Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide authority Support for site qualification and validation activities
• Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of critical metric/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

Key performance indicators:

• The relevant critical metrics that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results.
• Error rate: Number of OOS (analysis errors) related to the number of analyzes -No complaints about official inspections.
• Individual performance is assessed using the PMP performance dialog together with the manager

Minimum Requirements:
Work Experience:

• 3-5years experience in Pharma/Manufacturing sector in analytical lab in.
• Collaborating across boundaries.
• a GMP environment/equivalent.

Skills:

• Continuous 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.

Languages :

• English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Division Operations Business Unit Pharmaceuticals Location Indonesia Site Jakarta Company / Legal Entity ID03 (FCRS = ID003) PT Novartis Indonesia Functional Area Quality Job Type Full time Employment Type Regular Shift Work No

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