Senior Specialist, Quality Management Systems

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

To implement and maintain the quality management systems and to support Quality Assurance tasks including SAP.  The role will manage master data creation and maintenance in Waterford while supporting the Global Quality Team, certificate of analysis, and management of issues related to SAP QM.  The role may also lead quality systems projects and support in other quality related projects. 

 

Essential Duties and Responsibilities:

The person will have a strong understanding of quality systems and associated platforms.
 

• Implement and Manage the electronic systems and associated procedures supporting CAPA, OOS, Deviation, Change Control and Audit Management,
• Provide Quality Systems training
• Provide Management review metrics and required periodic quality reports metrics
• Management of quality related activities within SAP, including SAP QM EU/AP and NA
• Management of development with SAP QM
• Manage vendor complaints
• Master Data Management for Quality
• Review Customer specifications
• Lead Quality Systems Projects and support other quality related projects
• Identify and develop opportunities to improve existing processes and procedures in line with corporate
• Ensure continuous improvement of processes to ensure quality product and customer service
• Interface with other West sites with respect to sharing of best practices.
• Support the site training program with respect to the quality requirements
• Support Global Quality Systems team
• Provide support to quality engineers as required
• Provide support for customer requests
• Provide support to customer compliance for customer complaints 
• Run and provide reports with key quality metric data
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
• Participate in internal and external audits to ensure that site maintains high standards and strong quality systems
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.

 

Basic Qualifications: 

Required:

Third Level Qualification in an Engineering, Quality or Science discipline.

 

Preferred Knowledge, Skills and Abilities:

• 5+ years Quality Assurance Experience in a regulated environment
• Knowledge of Good Manufacturing Practices (cGMP) requirements

 

Desired

• SAP QM experience

 

Competencies 

• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.

 

Travel Requirements:

• This role will initially require travel for training and subsequently up to 6 weeks travel/year.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legall