QA Associate II
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business
The Opportunity
**Insert overview here**
Role Responsibility
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- Ensuring compliance to the relevant internal and Global Dechra SOP’s/Policies as well as local and international standards/regulations.
- Develop and promote a sustainable culture of quality within the business unit working with the BU and Site Leadership team.
- Quality metrics and KPIs.
- Data trending and tracking and assist in Management Review Meetings.
- Update compliance requirements based on change management.
- Coordinate a cross-functional team to deliver APQRs in a timely manner.
- Supporting a quality/continuous improvement culture within operations, where all team members are engaged in and participate in continuous improvement activities.
- May assist in New Product/Existing Product Development activities.
- Facilitate specification/master batch record creation.
- Support internal and external audits including regulatory agency inspections and supplier audits as well as help manage internal and self-assessment audits. Training and development will be provided.
- Assist QA OPS manager with supplier qualification activities as needed.
- Additional duties as assigned.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:
The Skills for Success:
- Have strong leadership skills.
- Possess the ability to multi-task, set priorities and meet strict deadlines.
- Have excellent communication skills, including presentation skills, listening, writing, and verbal.
- Be committed to Customer Service, Continuous Improvement and driving Quality Culture.
Knowledge and Experience:
- Preferred a minimum of 4 years in a quality assurance role in a high-volume manufacturing setting.
- Preferred experience in GMP manufacturing and compliance with demonstrated knowledge and experience of internal process/systems, as well as experience of related quality assurance principles applicable to pharmaceutical manufacturing.
- Preferred to have competency in management and tracking of Quality Metrics; Change Management, CAPA, Deviations, Root-Cause Analysis, Risk Management, Customer Complaints, APQR, auditing and audit reports.
- Previous experience working with FDA and local regulatory agency inspections.
- Experience at conducting deviation investigations using appropriate Root Cause Failure Analysis and Risk Management tools.
About the Company
As a people first values-based culture, we offer a generous employer 401k match and other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.