Quality Assurance Engineer- QC/Validation

Virbac
Bridgeton, Missouri, US
Full-time

Experiencing together a unique human adventure Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution.

Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams.

We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives.

Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

Virbac Animal Health is seeking a Quality Assurance Engineer - QC / Validation for our Quality Assurance team. This position will serve as Quality Assurance oversight for either Quality Control (QC) data, documentation, and projects or Validation documentation and projects being executed at Virbac.

The position will also assist with these activities for third party manufacturers on behalf of Virbac, as necessary. This position works directly with QC or Validation, and Project management to integrate Quality into industrial operations.

Virbac is an animal health pharmaceutical company that specializes in dental, medicine, and supplements for dogs, cats, and ferrets in the United States.

All candidates should make sure to read the following job description and information carefully before applying.

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 and hybrid schedules based on department and role within the department and much more! Responsabilities Area of responsibility 1 : Regulatory Compliance .

Main activities will include either one of the following :

QC Oversight : Serve as QA reviewer and approver of QC release, stability and raw material data (analytical 90% and microbiology 10%)

Serve as QA reviewer and approver of laboratory equipment and method validation protocols and plans for adequacy and completeness.

Review SOPs for accuracy and compliance; draft revisions for updates as necessary.

Maintain a current QC knowledge of applicable governmental regulations and their applicable to similar industries.

Validation Oversight : Serve as QA reviewer and approver of site validation protocols and plans for adequacy and completeness for equipment, cleaning, processes and computer systems.

Provide guidance on validation and testing strategies.

Review validation SOPs for accuracy and compliance; draft revisions for updates as necessary.

Maintain a current knowledge of applicable governmental regulations and their applicable to similar industries.

Expected results : Ensures QC and / or Validation documentation meets Virbac and Regulatory requirements.

Area of responsibility 2 : Quality Assurance

Main activities will include either one of the following :

QC Oversight : Review and approve OOS / OOT investigations for raw materials, intermediates and finished product testing.

Provide QA reviews and approvals of QC procedures, methods, change controls, CAPAs, deviations, and other documents, as necessary.

Track completed QC testing and OOS investigations and report regularly to Management.

Ensure that projects are executed per the Analytical Project Plans

Keep current on procedures related to QC operations.

Validation Oversight : Review and approve investigations as related to the execution of the project or validation.

Provide QA reviews and approvals of Validation procedures, methods, change controls, CAPAs, deviations, and other documents, as necessary.

Ensure that projects are executed per approved Validation Plans

Keep current on procedures related to Validation operations.

Provide quality oversight to project teams.

Direct, review and approve all investigations as it relates to the execution of project, validation and Out-of-Specification.

Ensure the project is executed per the Quality Assurance and Master Validation Plans.

Expected results : Ensures the Quality Group reduces quality risk to Virbac and its customers.

Area of responsibility 3 : Quality Planning .

Main activities can include :

Identifies and presents evidence of quality and compliance risks to QA Management as they appear.

Design and develop quality improvement strategies and plans.

Propose quality improvement actions and report regularly on implementation progress.

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 functions and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.

Expected results : Ensures the Virbac Quality Group strategically plans resources for continuous improvement in compliance.

Profile Requirements (Diploma and experience) Bachelor's degree in Biology, Chemistry, Engineering or related field and experience

7+ years human or animal pharmaceutical quality, with a preference for pharmaceutical quality experience Skills Current knowledge of analytical and / or validation principles, local and international regulations and regulatory policies.

Demonstrated skill in effective teamwork, communicating with other departments, customers, employees at all levels of the organization.

Demonstrated ability to make risk-based assessments for the Value Stream requiring a high degree of understanding of the overall site objectives.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension. Joining Virbac means joining dynamic teams ambitious for success. Add Your Talent to Ours!

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1 day ago
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