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QUALIFIED PERSON
Company:CBS BUTLER |
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Job Reference Number |
13426700 |
Client ID: |
RI/RWA4523 |
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Posted On: |
Jun 8 2009 |
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Location: |
CORK, CORK |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Role:
Will be named on the company licence as QP.
* Ensure batches are certified/dispositioned appropriately in accordance with all required regulations and in compliance with marketing authorisation.
* Provide Quality leadership, direction and governance for the specific area of responsibility.
* Manage quality-related matters specific to area of responsibility.
* Is responsible for approving appropriate quality-related documents. An approval signature confirms that Lilly, GMP and appropriate regulatory requirements have been met.
* Performs ongoing monitoring that includes:
- monitoring of quality systems
- the self-inspection program
- verification of the effective implementation of key GMP programs and
- review of systems that impact safety, identity, strength, purity, quality (SISPQ) to ensure that they operate in a state of control
Responsibilities:
May hold BSc, MSc or PhD in Chemistry, Biochemistry or a related discipline. Must hold Higher Diploma in Pharmaceutical Manufacturing Technology (QP).
* Must have at least 2 years experience operating as a QP or in a related role in a licensed manufacturing facility.
Please call Rachel Walters at CBSbutler on 021 4217446, or email rwalters@cbsbutler.com
Keywords: QA, QC, Biochemistry, FDA, GMP, Audit, Validation, Commissioning, Equipment, Testing, HPLC, Immuno-assay, SPC, Statistics, Minitab, Quality Engineer, Manager, PhD, MSc, Process Development, Mechanical, Manufacturing, Trouble shooting, Process Improvements, Chemical Engineering, CNC, Pro- Engineer, Metrology, SIX SIGMA, LEAN MANUFACTURING, Black belt, green belt
