Shire Sr Quality Assurance Specialist in Dublin, Ireland

• Managing priorities and tasks at Contract Manufacturers / Distributors

• Designing, implementing, and improving quality systems and metrics

• Reviewing and approving batch records, specifications, deviations, change controls, and SOPs

• Leading investigations

• Leading meetings with Contract Manufacturers

• Building authentic relationships with Contract Distributors/Manufacturers

• Leading audits

• Maintenance of Technical Quality Agreements (TQAs)

• Facilitating product complaints investigations

• Facilitating product recalls and associated investigations

• Leading and assisting in regulatory agency inspections

• Supporting Product Quality Reviews

• Providing training and supporting the QA learning management systems

These activities include:

• Management of quality systems (including but not limited to deviations, documentation management, change controls, returns, recalls, self-inspections, customer complaints, and vendor assurance pertaining to all SPIL products.

• Applying principles of risk management in the execution of their duties related to product quality, safety and efficacy.

Education and Experience

Essential

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

Experience working in Quality Assurance supporting the manufacturing / packaging of drugs, biologics, or devices.

Thorough understanding of quality systems and GMPs

Experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms

Experience participating in CMO/Vendor audits

Interpersonal skills and professional skills to interact with contractors while representing Shire

Must be able to read, understand, speak and write technically and legibly in English

Desired

Operational experience with drug product manufacturing and packaging, especially with aseptic/sterile processing

Experience working with multiple sites/locations

Experience working with contract manufacturing organisations

Lead auditor experience

Key Skills, Abilities, and Competencies

Candidates will have the following:

• Excellent organizational skills

• Time management and prioritization competencies

• Critical thinking/evaluation of process problems

• Strong work ethic

• Ability to trend and evaluate data

• Ability to multi-task in environment with changing priorities

• Proactively addressing compliance issues and escalate appropriately

• Ability and experience to develop gap analysis and action plans

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

• Build on Integrity: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment

• Risk a “Risk”: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference.

• Act on the Needs of Patients: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with.

• Vie to Be Better Than Yesterday: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress everyday to avoid the complacency that prior success may bring.

• Exemplify Trust & Openness: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges

Complexity and Problem Solving

Evaluation of batches assessing impact to safety, identity, strength, quality, or purity

Evaluation of changes to regulatory filings and/or validated systems

Knowledge of QP function, Manufacturing/Wholesaler Authorisations, Marketing Authorisations

Impact of schedule changes to clinical and commercial supply

Internal and External Contacts

The job is accountable to the Associate Director - Qualified Person to ensure that Shire is meeting its obligations to release medicinal product that is in compliance with its marketing authorisation that meets the requirement for continuity of supply and that meets business requirements

Contacts

• QA colleagues and Qualified Persons (internal)

• Supply Chain (internal)

• Customer Services (internal)

• Contract Manufacturing Organisations (external)

• Distributors (internal and external)

Other Job Requirements

• Periodic international travel is required for initial and on-going training, business meetings with contracted distributors, regional quality team, corporate peers/collaborators and vendors/contractors,

• Technical report writing, including but not limited to, authoring and reviewing audit reports, complaint investigation reports, standard operating procedures and impact assessment reports

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.