QUALIFIED PERSON
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Job Reference Number |
13317932 |
Client ID: |
RI/20738 |
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Posted On: |
May 21 2009 |
Location: |
CORK |
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Job Type: |
Permanent
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Salary: |
DEPENDENT ON EXPERIENCE |
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My Cork based client has a vacancy for a Qualified Person:
Qualified Person (QP)
Reports to: Quality Assurance (QA) Team Leader
Core Responsibilities:
• 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 the company’s, 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.
Required Qualifications & Experience:
• 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.
Salary dependent on experience
To take advantage of this opportunity call Tanya on (090)6493882 or send your cv