QC Supervisor

-Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing.

About the Role

Major accountabilities:

• CAPA definition, KPI trending, and ensuring all activities are in compliance with cGxP, including data integrity review and approval of analytical data/tests (analytical release).
• Stability testing (Projects) – protocol preparation, evaluation, and 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 including 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 analyses - No complaints about official inspections.
• Individual performance is assessed using the PMP performance dialog together with the manager.
• Functional breadth.
• 3-5 years experience in Pharma/Manufacturing sector in analytical lab.

Skills:

• Dealing with ambiguity.
• Decision-making skills.
• GxP.
• Industry standards.
• Laboratory equipment.
• Laboratory excellence.
• Quality control (QC) testing.
• Quality control sampling.
• Technological expertise.
• Total quality management.

Languages:

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