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As a primary responsibility, this position will be responsible conducting Document Peer reviews of audit project deliverables, e.g., Audit Agenda/Plans, Audit Announcement Letters, Audit Reports, Audit CAPA summaries, etc.  These deliverables are supporting documents from planned and completed Audits and may include other compliance related documentations such as SOP drafts, plans, policies, and forms.

The position of GxP Document Peer reviewer will work to help ensure ProPharma Group’s Global Auditing Program supports internal PPG and external client timelines.

As a secondary responsibility, this position will be responsible for planning and conducting GxP audits as applicable to experience (e.g., CMO, CRO, mock regulatory inspection, PV, internal process, investigator site, etc.) on behalf of clients.  The position of GxP Auditor will also act as a Subject Matter Expert (SME) for clinical-related projects and will be responsible for developing and managing the clinical auditing program.  This position is responsible for independently managing clinical-related projects and providing consulting and contract services to clients as needed.  This position is also responsible for assisting with designing, implementing, monitoring and maintaining ProPharma Group’s clinical auditing program, policies and strategies and ensuring company compliance to GxP regulations, internal procedures and policies in cooperation with peers.

Essential Functions Include:

• The GxP Document Peer Reviewer will support PPG Auditors (fulltime and contract employees) with the peer review of draft client deliverables. 
• Review documentation using technical experience and compliance against federal/national regulatory requirements as appropriate to project scope.
• Execute audits based on experience and a comprehensive understanding of all federal and international regulatory requirements and ICH (International Council for Harmonization) guidance.
• Keep pace with advances and technological changes in clinical support 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 clinical compliance 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.
• Promote continual improvement regarding customer satisfaction with emphasis on GxP auditing services.
• Ability to organize and manage projects.
• Quality orientation and high attention to detail.
• The role will guarantee the continued success of the company by ensuring that employees, contractors, and the company as a whole meet or exceed established quality and compliance guidelines with the documentation delivered.
• Apply strong editorial skills for the review and approval of GxP 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.

Qualified candidates must have:

• B.Sc./BPharm in scientific discipline as a minimum with experience. MSc/MPharm/MBA plus lead auditor /auditor certification preferred.
• Minimum 10 years of Quality, Compliance, and or auditing experience in related GxP regulated industry.
• Ability to interact in a professional and positive manner with clients and co-workers. 
• Exceptional interpersonal and communication skills.
• Experience working with high performance teams.
• 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.
• An ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• 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.

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.

• The role is home based with appropriate travel to undertake assignments on client sites.
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***