Ceva Animal Health - US - Kansas City - Qualification of New Cooler (REF7940P)

Job Description

This Compliance Consultant position is responsible for independently executing and managing compliance-related projects and providing consulting and contract services to clients for quality related issues and regulatory/GMP, as needed. This position will support assigned quality assurance and regulatory/GMP compliance projects.

Essential Functions Include:

• Develop, optimize, and manage client Quality Management Systems and provide GMP consultation for assigned projects.
• Keep pace with advances and technological changes in compliance services and the pharmaceutical/medical device/biotech industries and promote those that will increase the company’s effectiveness and profits.
• Provide support to clients and all functional units of ProPharma Group as quality and regulatory compliance issues such as deviations and non-conformances arise.
• Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for helping to ensure compliance of ProPharma Group and client operations to quality principles and GMP requirements, and participation in the development of quality systems through SOP writing and training.
• Promote quality and compliance subject expertise through marketing support (e.g. blogs, publications, presentations, etc.) and through professional networking.
• Support the development of ProPharma Group policies and procedures for all applicable business units within the company.
• Ensure company compliance with all applicable internal and external policies procedures and industry best practices.
• Support the generation of proposals for Compliance and Quality Assurance -related projects.
• Audit projects for correct approach, consistency, and quality.
• Utilize expertise of quality systems and GMP compliance to support the performance of audits, Gap analyses, and risk assessments for clients.
• Perform Customer Service functions in response to client inquiries.
• Assist with interviews of ProPharma Group candidates.
• Extensive travel required.
• Other duties as assigned.

Qualifications

Qualified candidates must have:

• B.S./B.A. in scientific discipline as a minimum.
• A Graduate degree in a scientific discipline is preferred.
• Minimum 5 years’ quality management experience in related industry.
• Understanding of the criteria for selection for compliance and quality assurance consulting services in the pharmaceutical, medical device and biotech industries.
• Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.
• Demonstrated ability to lead people and get results through others.
• Quality orientation and high attention to detail.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, SOPs, etc.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Ability to manage and execute multiple tasks associated within the compliance, quality assurance and validation fields.
• Strong working knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents.
• Knowledge of the sales process in these industries is a plus.
• Ability to earn and maintain clients’ confidence through appropriate planning, organizing, controlling and directing of a project.
• Ability to think ahead and prepare action plans to achieve results.
• Excellent analytical skills and the ability to access and resolve difficult business situations.
• Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift reasonable weights (approximately 35 Ibs.), read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.

Additional Information

• All candidates must be legally eligible to work in the United States.
• We are an equal opportunity employer. M/F/D/V
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.