CSV Auditor

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

A Freelance CSV Auditor will be responsible for planning and conducting CSV audits (qualification, re-qualification, for cause and PAI readiness) on behalf of clients. The position of CSV Auditor will also act as a Subject Matter Expert (SME) for CSV auditing and supplier management projects.

This position is responsible for independently managing CSV auditing projects and providing consulting services to clients as needed. This position is also responsible for complying with ProPharma Group’s CSV auditing program, policies and strategies and ensuring company compliance to CSV regulations, internal procedures and policies in cooperation with peers.

Essential Functions Include:

• Subject matter lead for CSV auditing projects within ProPharma Group.
• Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH and GAMP 5 guidance.
• The CSV Auditor will be a critical team member who contributes to the implementation of a risk-based CSV audit program.
• Promote continual improvement regarding customer satisfaction with emphasis on CSV auditing services.
• Keep pace with advances and technological changes in CSV supplier management services within the pharmaceutical 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 supplier management and CSV auditing issues such as deviations and non-conformances arise.
• Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
• Also, is responsible for helping to ensure compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Ability to organize and manage projects.
• Quality orientation and high attention to detail.
• Strong working knowledge of international CSV requirements and standards. Utilize expertise of quality systems, data integrity, software compliance and CSV requirements to conduct audits and provide Gap analyses and risk assessments for clients.
• Perform Customer Service functions in response to client inquiries.
• Strong editorial skills for the review and approval of CSV 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.

Qualifications Include:

• B.S. B.A in scientific discipline.
• A graduate degree in a scientific discipline is preferred.
• Minimum 5 years of computer systems and CSV auditing experience in related industry.
• Pharmaceuticals Healthcare Life science industry validation experience. Ability to interact in a professional and positive manner with clients and co-workers.
• Exceptional communicator with strong persuasion skills and presentations. Excellent interpersonal and communication skills.
• High level of understanding of the criteria for selection for hardware, software and CSV auditing services in the pharmaceutical, medical device and biotech industries.
• Knowledge of the sales process in these industries.
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.
• Experience creating and working with high performance teams.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• Demonstrated ability to lead people and get results through others.
• Ability to think ahead and prepare action plans to achieve results.
• Supervisory experience, including employee hiring and retention, performance review and discipline.
• An ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Excellent analytical skills and the ability to access and resolve difficult business situations.
• Ability to 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.