Senior Quality Assurance Specialist

Vacancies

Senior Quality Assurance 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

Reporting to Sr. QA Compliance Manager, the Sr. Quality Assurance Specialist is responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements in the cGMP Quality organization.

***No third-party agencies, please***

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 QA oversight of manufacturing operations, production areas and equipment, facilities, warehouse, and laboratories.
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
• Review batch-related documentation and ensure resolution of issues to ensure timely disposition of product. Communicate lot disposition pending issues to Management.
• Perform quality review of manufacturing and laboratory investigations, product complaint investigations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed.
• Investigate quality events (i.e., deviation, product complaints) by performing a thorough root cause analysis, plan science-based hypothesis testing, develop an effective Corrective and Preventive Action (CAPA) plan, and prepare a comprehensive report.
• Gather quality metric information for use in continuous improvement of areas of responsibility.
• Generate, revise, and review standard operating procedures and other documents as needed.
• Review proposed changes to systems, procedures, and methods.
• Review validation-related documents, as needed.
• Perform internal audits for cGMP CFR 210/211 compliance as scheduled, compile findings, communicate results and recommendations for improvement, collaborate with auditees to develop audit response and corrective action plans.
• Review test records, raw data, and documents according to company procedures, data integrity and adherence to specifications. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data.
• Author technical reports (i.e., annual product quality review, audit reports), evaluate trends and escalate adverse trends to management.
• Participate in regulatory inspections and client audits as required.
• Perform other duties as required to fulfil department and business needs.

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:

• Minimum Education: Bachelor's degree in a Life Sciences or Chemistry discipline
• Minimum of 5 years of relevant cGMP experience in the pharmaceutical/biotech industry
• Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
• Experience with manufacturing and laboratory investigations, deviations, and CAPA.
• Experience with change control practices and strategies.
• Experience with internal audits.
• Familiarity with Root Cause Analysis tools.
• Familiarity with risk-based thinking or risk-based tools.
• Knowledge of equipment, facility, and utility IQ/OQ/PQ.
• Familiarity with various analytical equipment, techniques, and methodology.
• Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skills
• Ability to manage multiple priorities and re-prioritize tasks as required.

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.