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Validation Specialist - Des Moines, United States - Virbac
Description
Experiencing together a unique human adventureAnimal 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 ourbusiness.
Validation Specialist
Virbac Animal Health is seeking a Validation Specialist to join our MSAT team. The Validation Specialist prepares, executes, and summarizes
validation/qualification
protocols and other related documents (risk assessments, project plans, periodic reviews, URS, FRS, IQ/OQ/PQ, SAT, FAT etc.) to support the
validation/qualification
program at Virbac St. Louis.
The Validation Specialist also performs other activities related to compliance and providing validation support for manufacturing issues or special projects as needed.
Qualified candidates must possess a Bachelor's degree in atechnical/science/mathematical
field . The ideal candidate would have 3+ years of experience in GMP Field.
They would also possess experience in performing primary duties in pharmaceutical health care or a related regulated industry, writing/executing protocols and reports or similar activity.
Validation/qualificationexperience in a
biotech/pharmaceutical
environmental or related regulated industry preferred. Experience in the animal pharma industry and/or oral solid dosage industry are preferred.
This exciting position will work in Bridgeton, MO. It comes with an excellent benefits package including generous time off, 401k + match, life, medical, dental, and vision benefits, and more
Qualification and Validation Projects
Main activities:
Draft
qualification/validation
protocols that meet internal procedures, domestic and international regulatory requirements. Protocol subject areas may include system qualification, cleaning validation, computer system validation and process validation (PPQ). Protocols are developed to trace user, functional and design specification as applicable.
Additionally, create and/or revising other supporting documents, including URS, System Impact Assessments, functional and design specifications, risk assessments, periodic reviews, commissioning documents, validation project plans, and others.
Coordinate with maintenance and operations to develop all supporting documentation including cleaning procedures, instructions for use, maintenance work instructions and training plans.
Work with planning, laboratory, maintenance and operations to execute all systems and process testing and to complete the testing documentation.
Draft reports and draw conclusions regarding the appropriateness of the system or process for its intended use, including statistical analysis of data generated by validation studies.
Manage the document flow for protocols, working copies and completed reports through the entire life cycle, ensuring proper documentation on all protocol entries.
Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to equipment qualification projectsSupport Change Control processes, performing assessment of system changes, and execution of revalidation and/or re-qualification activities as needed.
Expected results:
Qualifications/validations
are completed appropriately, and on schedule as promised in the annual or specific project plan.
Continuous improvement of the Validation department
Main activities:
Develop, maintain and review for continuous improvement the use of protocol templates to develop consistency for all protocols and associated validation documents.
Expected results:
Contribute to the continuous improvement of the department with template and procedure creations/revisions.
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
Get in touch
Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match
About Us
Focusing on animal health, from the beginning
At Virbac, we provide innovative solutions to veterinarians, farmers and animal owners in more than 100 countries around the world.
Covering more than 50 species, our range of products and services enables to diagnose, prevent and treat the majority of pathologies.
Every day, we are committed to improving animals' quality of life and to shaping together the future of animal health.
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