QMS Specialist

Vacancies

QMS Specialist

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

The QMS Specialist will maintain and improve the Quality Systems within Dechra Pharmaceuticals Manufacturing in Fort Worth. Promote, develop and oversee compliance of company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement.

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:

• Provide oversight and management of the site Quality Management System including driving Continuous Improvement of key quality processes
• Improve existing and develop new Quality Processes, writing and implementing associated procedures and other documentation
• Interpret regulatory requirements and provide guidance for effective compliance, as well as providing coordination / support for programs and projects
• Establish, track and present visual Quality Metrics to support Quality Management Review of the effectiveness of the site Quality Management System
• Provide guidance for higher level decisions required for change management and deviation investigations
• Create, revise, process, and/or distribute Investigations, Failure Investigation reports, Supplier Corrective Action Reports, Internal Audit Reports, Deviations, Planned Deviations, and other technical documents when necessary
• Develop and support the technical writing capability on site including creating procedures, work instructions, forms, investigations, and audits
• Conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities
• Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues
• Assist with external audits including regulatory agency inspections (MHRA, FDA, EMA, etc.)
• Supply feedback to the Head of Quality and SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities
• Proactively influence management regarding the adoption of standards to improve quality, efficiency and compliance within Dechra

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:

• A Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related) is required.
• A formal qualification in quality assurance compliance management in regulated pharmaceutical environment
• Minimum of 3 years of experience in Pharmaceutical industry
• Experience in GMP manufacturing and compliance with demonstrated knowledge and experience of related quality assurance principles applicable to pharmaceutical manufacturing
• Competency in management and tracking of Quality Metrics- CCs, CAPAs, Deviations, Complaints, PQRs, audits and audit reports
• Previous experience working with FDA and participating in regulatory agency inspections
• Previous experience of project management, time management and people management
• Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment
• Ability to multi-task, set priorities and meet strict deadlines
• Using logic and reasoning to identify solutions to problems
• Ability to lead, motivate, coach, and teach others
• Ability to prioritize, demonstrating good time management skills
• Self-motivated, with the ability to work proactively using own initiative

About the Company

As a people first values-based culture, we offer a generous employer 401k match and an 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.