QC Supervisor

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 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 analyses - No complaints about official inspections.
• Individual performance is assessed using the PMP performance dialog together with the manager.

Minimum Requirements:

Work Experience:

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

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.

Skills Desired:

• Continued Learning.
• Decision Making.
• GxP.
• Industry Standards.
• Laboratory Excellence.
• Laboratory Instrumentation.
• Managing Ambiguity.
• Quality Control (QC) Testing.
• Quality Control Sampling.
• Self-Awareness.
• Technical Knowledge.
• Total Quality Management (TQM).