Job Introduction
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.
Dechra isa 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 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.
Reporting to a Quality Sr. Manager.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Review batch-related documentation and ensure resolution of issues to ensure timely disposition of product. Communicate lot disposition pending issues to Management.
Perform product quality complaint investigations and fulfil QMS reporting requirements
Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
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 quality review of manufacturing and laboratory investigations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed.
Investigate quality events 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.
Perform internal and external 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.
Collect and analyse laboratory data for the monitoring and evaluation of product quality and complaint trends.
Author technical reports (i.e., environmental monitoring trending, annual product quality review, audit reports), evaluate trends and escalate adverse trends to management.
Perform evaluations of new and existing suppliers and service providers, maintain approved supplier list.
Provide QA oversight of facilities, warehouse, production areas, and laboratories.
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 keen to hearfrom those who have/are:
Bachelor's degree in a Life Sciences or Chemistry discipline
Relevant cGMP experience in the pharmaceutical/biotech industry
ASQ Auditor Certified
Ability to travel approximately 15%
Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
Experience with manufacturing and laboratory investigations, deviations, product quality complaints and CAPA.
Experience with change control practices and strategies.
Experience with internal and external 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. Excellent problem-solving skills
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra Pharmaceuticals PLC
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