Shire QA Lead - Qualified Person (Non-Steriles) in Dublin, Ireland

Primary Role:

To act as a Qualified Person (QP) named on Shire’s manufacturing and Import Authorisation (MIA) licence under the direction of the Head QP, performing EU QP release and associated QP Good Manufacturing Practice (GMP) activities with responsibility for Shire finished dosages in accordance with their Marketing Authorisations ( national or European), their Manufacturing Authorisations and the principles and guidelines of GMP as laid down in Directive 2003/94/EC.

Responsibilities:

35%:

• To certify that batches of finished product to be released by Shire on the EC/EEA, have been manufactured and checked in accordance with the Shire Marketing Authorisation, the Manufacturing Authorisation, GMP and legal requirements as set out in Article 51 of directive 2001/83/EC

5%:

• To ensure that the legal requirements regarding imported products have been met

15%:

• To investigate any quality related deviations and support execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained

15%:

• To be readily available to staff of Shire for discussion and advice and also be present during regulatory inspections, if required

Education & Experience Requirements:

Essential:

• Bachelor’s degree in chemistry, biology or a related discipline

Desired:

• Quality experience in solid oral and parenteral biotech manufacturing (aseptic or sterile processing)

• Eligible to practice as a Qualified Person or Responsible Person.

• High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor).

Key Skills, Abilities, and Competencies:

• Organization

• Critical thinking/ evaluation of process problems

• Data trending and evaluation

• Ability to multi-task in environment with changing priorities

• Strong work ethic

• Ability to work independently

• Living the values at Shire is a basic expectation for all Shire employees. Shire expects all employees for live the BRAVE values:

B – Bold: We have the courage to lead the way

R – Resilient We are agile and adaptable to meet the changing needs of our stakeholders

A - Accountable: We deliver on our promises to all of our stakeholders.

V - Visionary: We fearlessly innovate to address unmet patient need.

E - Ethical: We do the right thing, in the right way

Other Job Requirements:

• Ability to work during routine business hours but be flexible to cover US business hours

• Ability to travel approx. 25%

About Shire:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.