QC Coordinator

Requirements

• 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.
• 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

Additional Information

Job Description Summary -Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing. Job Description 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 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 Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: The relevant KPIs 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: Functional Breadth. 3-5years experience in Pharma/Manufacturing sector in analytical lab in. Collaborating across boundaries. A GMP environment/equivalent.

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