Virbac, shaping the future of animal healthFounded in 1968 by a French veterinarian, Virbac is an independent pharmaceutical laboratory since always dedicated to animal health. Currently ranked 7th worldwide, the company is present in more than 100 countries, offering a comprehensive and practical range of products and services covering the majority of species and pathologies. Virbac innovation, based on both technological advances and listening to the customers, relies on reactive production facilities which meet the highest international quality standards. For nearly fifty years, these specific features have allowed the company to build a personalized relationship with veterinarians and farmers in every country. Through this privileged partnership, in which social, health and environmental issues come together, Virbac contributes, day after day, to shape the future of animal health.Quality Engineer I - QC/ValidationMissionThis 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.Permanent AssignmentsArea of accountability no.1: Regulatory ComplianceMain activities will include either one of the follow: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 site validation protocols and plans for adequacy and completeness for equipment, cleaning, processes and computer systems.* 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 industry.Validation Oversight* Serve as QA reviewer and approver of laboratory equipment and method validation protocols and plans for adequacy and completeness.* Provide guidance on validation and testing strategies.* Review SOPs for accuracy and compliance; draft revisions for updates as necessary.* Maintain a current knowledge of applicable governmental regulations and their applicable to similar industry.Þ Expected results: Ensures QC and/or Validation documentation meets Virbac and Regulatory requirements.Area of accountability no.2: Quality AssuranceMain 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 and/or Validation 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 the Validation Plans* Keep current on procedures related to QC and/or Validation operations.* Provide quality oversight to project teams.Þ Expected results: Ensures the Quality Group reduces quality risk to Virbac and its customers.Area of accountability no.3: Quality PlanningMain 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.Þ Expected results: Ensures the Virbac Quality Group strategically plans resources for continuous improvement in compliance.KNOW-HOW: job-related skills required to complete activitiesA thorough understanding of cGMP pharmaceutical laboratory requirements and best practices based on FDA, ICH, EU (and others) regulations.Ability to read, write and interpret documents such as protocols, safety rules, operating and maintenance instructions and procedure manuals. Familiarity with process development, process transfer, method development, and/or validation principles. Ability to persuasively communicate using excellent written and verbal skillsIT: Proficiency in Microsoft Word, Excel and Power Point. Knowledge in laboratory software systems a plus.Languages (specify level): Languages (specify level): English - fluentBEHAVIOUR: interpersonal skills required to complete activitiesValidated Skills Model: INDIVIDUAL CONTRIBUTOR1. Analyze problems and situations2. Demonstrate the ability to anticipate and plan3. Communicate effectively4. Adapt to Change5. Demonstrate teamwork and develop cross-functional cooperationOptional: Training / Experience necessary to fulfill the jobEducational level or equivalent experience: Bachelors degree in Chemistry, Biology or related fieldTotal number of years' experience required to fulfil the role: 7 years human or animal pharmaceutical experience, with a preference for pharmaceutical quality experience.Career pre-requisites:Current knowledge of analytical and validation principles, local and international regulations and regulatory policies.Demonstrated skill in effective team building, communicating with other departments, customers, employees at all level of the organisation.Demonstrated ability to make risk-based assessments for the Value Stream requiring a high degree of understanding of the overall site objectives.Challenges: context: Cross-disciplinary relationships and / or main threats and/or opportunities - external and internal - which may impact the job's activities1. Internal: Frequent contact with QC, Validation, R&D, Supply Chain, project management, and co-workers2. External: Periodic contact with regulatory entities and government related representatives. Frequent contact with contracted services (eg. laboratory contractors, Validation contractors, and design and engineering firms).You're willing to join a dynamic team in a growing company ?Virbac is committed for several years to promote diversity and equal opportunities especially on the issue of disability. All positions are open to people experiencing disability.
Location/Region: Saint Louis, MO (63150)