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Hybrid Sr AS&T Analyst bei Novartis

Novartis ·  Guido Caloi, Vereinigte Staaten Von Amerika · Hybrid

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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 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.


 

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
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