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QUALIFIED PERSON

 

Job Reference Number

14059280

Client ID:

RI/PDQUALPAV

Posted On:

Aug 25 2009

Location:

CORK

Job Type:

Permanent

Salary:

€ 60,000 - € 100,000

Qualified Person

Our prestigeous multinational client is a leading innovation-driven pharmaceutical corporation. They are developing a growing portfolio of best-in-class, first-in-class pharmaceutical products by applying the latest research from their own worldwide laboratories, by collaborating with eminent scientific organizations, by making use of the most up-to-date technological tools and by providing exceptional service to their customers. Through these internal programs and external initiatives, they're seeking answers for some of the world's most urgent medical needs. As their products save and improve lives, they also save overall health care costs: they are often less expensive than other forms of health care, such as surgery and hospitalization. They employ approximately 42,000 people worldwide and market their medicines in 143 countries. They have major research and development facilities in nine countries and conducts clinical trials in more than 60 countries

Qualified Person

Location: Cork

Reports to : Quality Assurance (QA) Team Leader

Minimum Experience required;

Must have at least 2 years experience operating as a QP or in a licensed manufacturing facility.

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 , 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, Engineering or related discipline.
  • Must hold Higher Diploma in Pharmaceutical Manufacturing Technology (QP).


Contact:

Paul Dooley,
Firstaff Personnel Consultants,
85/86 Grafton Street,
Dublin 2. Ireland.

web page - http://www.firstaff.ie/
email - paul@firstaff.ie
Phone +353 1 6797766 Fax +353 1 6796281
Mobile +353 86 252 9015