摘要
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 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.
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.
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