Quality Systems Auditor

ID# DCPA27684

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Major Responsibilities: 

  • Independently leads the planning, conduct, and reporting of R&D QA audits/reviews/inspections of R&D GxP/nonregulated activities, data, internal facilities, systems/processes, and computerized systems, and external service providers to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements. 
  • Issues audit/review/inspection reports of audit findings. Effectively communicates findings to auditees and participates in the CAPA process following company procedure. 
  • Performs peer review of audit reports as appropriate to function. 
  • When participating in audits/analyses of data and systems/processes throughout globalresearch departments (e.g., non-regulated) effectively applies state-of-the-art quality knowledge and best practices. 
  • Manages and resolves difficult technical and tactical issues according to departemental/company procedures and regulations. 
  • Develops expertise in at least 2 GxP/non-regulated disciplines. 
  • Ensures the relevant development plans and diagnostic tools, created by the Strategic Group per GxP/non-regulated discipline, are fully understood and applied in daily activities. 
  • Assists in the facilitation of Health Authority inspections at respective Janssen R&D site, clinical investigator site, or external service provider. 
  • Assesses the current quality of R&D GxP/non-regulated related systems and makes recommendations for improvement. 
  • Contributes to process improvements and ongoing development of new auditing procedures, techniques, and department guidelines. 
  • Writes or revises R&D QA SOPs. Reviews and contributes to the development and revision of other departmental SOPs. 
  • Routinely interacts with internal/external appropriate functional personnel, to identify issues and recommend actions as solutions to issues identified throughout the audit/review/inspection process. 
  • Takes action on solutions of moderate to difficult regulatory and technical complexity. Seeks supervisor’s advice on issues as needed. 
  • Monitors new regulatory legislation or guidelines, which have direct impact on R&D GxP/non-regulated regulatory compliance activities and where appropriate disseminates this information to members of other functional areas such as, but not limited to Preclinical Development, Clinical, Global Clinical Operations (GCO), Global Medical Safety (GMS), and Global Regulatory Affairs. 
  • Responds independently to R&D GxP/non-regulated related compliance inquiries from other departments. 
  • Confers with professional staff when contacted for pro-active consultation to provide regulatory insight regarding specificissues or special circumstances identified by professional staff to obtain a department unified position. 
  • Participates in special projects, Licensing and Acquisition Due Diligence assessments, and serves on project teams related to R&D QA functional issues as assigned by supervisor. 
  • Serves as a subject matter expert within functional area. 
  • Producing results that strongly impact the achievement of departmental goals. 
  • Maintaining a state-of-the-art compliance knowledge and a high quality profile inside the company. 
  • May accomplish results through entry or low-level exempt employees when assigned. 

Position Qualifications: 

Working Relationships/Interfaces: 

  • Interacts with peers and supervisors in R&D QA and relevant development area to execute job activities. 
  • External contact may include study specific professionals (e.g., study monitors, directors, investigators, and external service providers), operating company personnel, and industry colleagues/contractors at professional and managerial levels. 

Education: 

  • A Bachelor of Science (BSc) degree in a life, natural, or computer science and preferably 5 years in an R&D environment or the equivalent in training and experience is required. 

Related Experience: 

  • Comprehensive knowledge of the drug development process, worldwide GxP/non-regulated compliance regulations, R&D practices, and scientific and quality terminology. 
  • Expert knowledge in one or more specific compliance discipline (non-regulated, GLP, GCP, PhV, or Computerized Systems). 
  • Excellent oral and written communication skills, organized, and detail oriented. 
  • Excellent problem solving and negotiating skills; established networking experience. 
  • Use of current computer Microsoft Office Suite programs. 

Position Details:

Medical Device

Engineering

Start Date: 
11-4-2013
End Date: 
12-31-2013

SPRING HOUSE , PA

CON_W2

40

DCPA27684

No

No