ProPharma Group

GVP Auditor - 100% REMOTE WORKING - UK or EU BASED - REF11188N

ProPharma Group

ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. Our clients’ business needs and issues are our primary focus. Client speed to market, aggressive deadlines, and a challenging and changing regulatory environment are factors that experienced PPG personnel can assist your organization with in meeting and realizing its competitive advantage.

ProPharma Group has developed long-term relationships with clients to whom we provide a wide array of value - added services that complement and support their core business needs. We understand what it takes to deliver a project In-Budget, On-Time, and In-Compliance!

ProPharma Group offers the excitement of a consistently evolving career. Our consultants and colleagues are continually learning and working on new and stimulating projects in a variety of regions. The opportunity to travel and work with industry leaders throughout the United States awaits you!

We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, rigorous and entrepreneurial spirit of the company culture.

ProPharma Group develops long-term relationships with clients across the country to which we provide a wide array of value-added services that complement and support their core business needs. We know our employees and consultants are critical to our success in providing the best possible service to our clients.
Overland Park Kansas, United States
http://www.propharmagroup.com
Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, Indian, Ireland, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

The Auditor is responsible for the conduct, reporting and tracking of internal and vendor audits on behalf of ProPharma Group.

Essential Functions Include:

  • Act as lead auditor during ProPharma Group’s internal and supplier audits.
  • Support the development, approval, maintenance, and management of the internal and supplier audit programs (schedules) in the electronic Quality Management System (eQMS) for ProPharma Group globally, including liaison with relevant colleagues to complete performance of required audit/qualification activities. Ensure internal / supplier audit documentation is completed and attached in the system.
  • Support the development of processes and procedures to ensure best practices are adhered to.
  • Maintain ProPharma Group PV audit universe and perform annual risk assessments for audit scheduling.
  • Document findings and corrective/ preventive actions identified from internal and supplier audits into eQMS, as necessary.
  • Support the maintenance and management of the external (client) audit program in eQMS for ProPharma Group globally and assist relevant colleagues during audits and inspections from the competent authorities, as necessary.
  • Support development, implementation, and maintenance of readiness materials/ resources to support colleagues during audits and inspections. e.g., training, slide decks, templates.
  • Support the development, implementation, and management of a global training program for ProPharma Group auditors who lead internal and supplier audits.
  • Review and update ProPharma Group quality documents as needed to support the department.
  • Maintain awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of ProPharma Group services on behalf of the pharmaceutical industry.
  • Identify efficiencies and improvements within the Quality Systems team by assessing existing processes and providing recommendations.
  • This position may also be involved in other aspects of the ProPharma Group Quality Management System globally, as delegated by Quality Leadership.

Qualifications

Qualified candidates must have:

  • Required: Bachelor’s degree or a combination of Associates degree with certification plus extensive related experience.
  • Preferred: Bachelor’s degree in the healthcare industry or a combination of Associates degree in healthcare plus experience in a healthcare field.
  • Experience in a pharmacovigilance auditing role essential.
  • Experience in clinical pharmacovigilance and/or computer systems validation auditing preferred.
  • Proven track record of successful delivery of internal and supplier audits.
  • Able to work within a team in an open and professional manner and work effectively with colleagues in other departments to achieve Company goals.
  • Excellent attention to detail and focus on quality.
  • Excellent computer literacy.
  • Excellent verbal, written and interpersonal communication skills.
  • Sound planning, prioritizing and organizational skills, including advance preparation for meetings.
  • Able to work independently and collaboratively with minimal supervision.
  • Strong internal and external customer service skills.
  • Must be able to interface with a variety of people with different technical levels and educational backgrounds; must be detail oriented and highly organized.
  • Critical Thinking – Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

If you require alternative methods of application or screening, you must approach ProPharma Group directly to request this, as we're not responsible for the employer's application process.

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