Qc Senior Specialist I

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 Novartis 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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