Quality Systems Associate (Part – Time)

Job description

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Commercial  Liffey Valley Dublin

Opened in 1946, this operation, based in Liffey Valley Dublin was the first Abbott business unit to be established in Ireland. This business is responsible for the sales, marketing and distribution of a wide range of diabetes, diagnostic, and nutritional products in Ireland.

DEPARTMENT FUNCTION/OBJECTIVE

Support the management of the Quality Systems activities for the Global Region Third Party Manufacturing (TPM) and Supplier QA group, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.

PRIMARY FUNCTION:       

The Quality Associate is responsible for providing general QA support for assigned Quality Systems to meet cGMP and other applicable regulatory standards and the appropriate market requirements.

MAJOR DUTIES AND RESPONSIBILITIES:  

Support assigned activities related to the core Quality Systems of TPMQA, for example:

· 
Complaints System: support investigations for non-medical and medical (adverse events) complaints, including complaint trending using the Trackwise QA.IT system.

· 
Management Review: support preparation of Management Review information, metrics, reports review.

· 
Product Quality Reviews: Coordinate and support the system for the preparation of PQRs to ensure accuracy, completeness, timeliness, and that trends are identified and addressed in an appropriate manner.

· 
Coordinate and support the system for the evaluation and distribution of Regulatory Changes with the department.

SUPERVISORY OR MANAGERIAL RESPONSIBILITY

· 
Contact with Abbott personnel at many levels, different Functions and Affiliates

· 
Frequent contact with TPM personnel at Quality Systems level

· 
Continuous contact with TPM QA Managers and Director and appropriate supporting Cross-Functions (Regulatory, Supply Chain, etc).

    

PROBLEM SOLVING:    

· 
Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives

· 
Capable of analyzing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues

ACCOUNTABILITY:

· 
The Quality Associate will report directly to the lead Quality Systems Specialist and work closely with the TPM QA Managers and Quality Director.

    

SCOPE OF AUTHORITY:

· 
Support the management by providing relevant information for decision making,

· 
The position receives supervision via Quality Systems Specialist.

      

EDUCATION AND EXPERIENCE REQUIRED :                     

· 
Degree in a relevant Quality or technical/scientific discipline preferred.   

· 
Understanding of pharmaceutical manufacturing for finished dosage forms with experience in QA, Operations, or Technical Support in a pharmaceutical setting.

· 
Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s is an advantage.

· 
Proficient in use of common IT software applications: Excel, PowerPoint. Experience of SAP, Trackwise an advantage.

Connect with us at  www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at  www.facebook.com/Abbott  and on Twitter @AbbottNews and @AbbottGlobal.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Ireland > Dublin : Block B

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 35.0Hst0 (Ireland)

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable