Quality Assurance Engineer External jobs in United States
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Virbac · 8 hours ago

Quality Assurance Engineer External

Virbac Corporation is seeking a Quality Assurance Engineer - External for their Quality Assurance team. This role involves conducting external functions for Quality Assurance, including assessing CMO compliance, overseeing suppliers, and managing quality risks to ensure adherence to regulatory standards.

Animal FeedPharmaceutical

Responsibilities

Ensure Suppliers meet industry and Virbac standards set forth by Regulatory agencies and Virbac
Ensure supplier qualification is performed per established Virbac policies and meets all regulatory requirements for all applicable government agencies
Assist in development and maintenance of audit schedules
Proactively identify and manage changes in controlled processes and procedures following changes in industry practices or regulations, ensuring high quality standards with applicable laws, regulations, guidelines, and Virbac policies
Support New Product Launches for new third party products to meet project timelines
Review and approve deviations, batch documentation, Out-of-Specification, Out-of-Trend and change requests from suppliers
Trend performance metrics for suppliers and report regularly to help identify potential shifts in supplier performance before supply is impacted
Track post-audit improvement actions and report regularly on implementation progress
Perform effectiveness audit of the implemented improvement actions
Identify and present evidence of quality and compliance risks to QA Management as they appear. This includes but is not limited to Quality Agreements (QAAs), registration batches, stability, Process Validation (PV), and product launches
Assist with management of supplier assessments and the Virbac Approved Supplier List
Assist with management of Supplier Corrective Action Requests (SCARs) related to any of the third party products we manage
Perform, track and manage actions required to maintain a compliant supplier qualification program
Identify and present evidence of quality and compliance risks to QA Management
Design and develop quality improvement strategies and plans
Support CMO/CPO changes, review batch records, and validation review among other duties such as generating supplier metrics, presenting in quality system management review
Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/Risk Management, Clinical Operations and Regulatory to ensure appropriate cross-functional SOPs, policies or work instructions are in place and followed
Provide regular updates to senior management, and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships

Qualification

GMP ComplianceSupplier QualificationQuality Assurance OversightAnalytical PrinciplesValidation PrinciplesRisk AssessmentAutonomous Decision MakingCommunication Skills

Required

Bachelor's degree in Biology, Chemistry, Engineering or related field
Total number of years' experience required to fulfil the role: 4-8 years
Current knowledge of analytical and validation principles, local and international regulations, and regulatory policies
Demonstrated skill in communicating with other departments, customers, and employees at all levels of the organization
Demonstrated ability to make risk-based assessments requiring a high degree of understanding of the overall site objectives
Demonstrated ability to work autonomously and make courageous and sound decisions

Benefits

13 Company paid Holidays
5 personal days (prorated)
15 vacation days (prorated)
5 floating holidays (prorated)
6% 401k match
Competitive pay and bonus opportunity
Growth opportunities
Hybrid schedules based on department and role within the department

Company

Virbac

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Virbac is a pharmaceutical company producing animal food & medicine for veterinarians, breeders & owners to deal with animal pathology.

Funding

Current Stage
Public Company
Total Funding
unknown
1999-04-01IPO

Leadership Team

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Habib Ramdani
Group CFO - Deputy CEO
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Paul Martingell
Chief Executive Officer
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Company data provided by crunchbase