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QA Associate (Temporary) - Ireland  

Company managed [?] Still accepting applications

Posted on : 27 January 2017

Project Description


Description
  • Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. 
  • We will continue to focus on advancing therapies that are the first or best of their kind.          
  • By providing a foundation for all operations company wide,our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. 
  • Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.      
  •  We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.      
  •  A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.      
  • The Quality Assurance Associate reports to the Quality Assurance Manager, and is responsible for supporting site quality systems, site start-up, inspection readiness and assisting with the batch release process for drug substance.       


RESPONSIBILITIES         
  • Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives         
  • Support the Technology Transfer of a new product into the site including raw material and supplier qualification.         
  • Support quality systems on site         
  • Review and approve standard operating procedures (SOPs) and master batch records.         
  • Review and approve deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. 
  • Assist with internal audits to ensure compliance with cGMPs and other regulatory requirements.          
  • Assist with regulatory inspections.         
  •  Support the following activities, as appropriate:         
    • Document Control         
    • New or updates to relevant quality agreements         
    • Validation activities         
    • Annual Product Reviews         
    • Complaints, recalls and/or notification of events to regulatory agencies         
    • Other duties as assigned       

EDUCATION         
         • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.       


 EXPERIENCE         
  • Minimum 5 years’ relevant experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.         
  • Strong ability to communicate, present data, and defend approaches in front of audiences and inspectors.         
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.         
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.         
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.        


CONTACTS         
  • This position will require interaction with multiple levels in Quality Assurance, Quality Control, Contract manufacturers, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.       
  • This description is not intended to be all-inclusive or a limitation of the duties of the position.  
  • It is intended to describe the general nature of the job that may include other duties as assumed or assigned.