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QUALIFIED PERSON

 

Job Reference Number

13317932

Client ID:

RI/20738

Posted On:

May 21 2009

Location:

CORK

Job Type:

Permanent

Salary:

DEPENDENT ON EXPERIENCE

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