Sr. Compliance Specialist-Global QA Computer Systems

Sr. Compliance Specialist-Global QA Computer Systems

At Infotree Global Solutions

Date Posted:

Location: USA Only, TELECOMMUTE



Company Description



Job Description

Job Title:                     Sr. Compliance Specialist-Global QA Computer Systems

Work Location:         US- Remote, North Carolina

Contract Position:    4 months(Possibility for extension)

 

Job description:

  • The Senior Compliance Specialist- Global QA Computer Systems, will provide quality oversight and support for global system applications and processes within the Global Quality Compliance Team within Pharmaceutical Services Group.  This person will collaborate with system owners and business process owners to meet business and regulatory requirements that are inclusive of system design, validation, implementation and lifecycle management.

 

Education / Experience

  • Bachelor’s Degree or higher in Science, Engineering or QA/Regulatory related course of study
  • Minimum of 7 years’ experience in a regulated industry with direct pharmaceutical experience in QA, QC or Regulatory Affairs
  • Experience with GxP computer system regulations and GAMP 5

 

What You Will Do:

  • Review and approve regulatory required documentation and ensure compliance, corporate, and procedural requirements are met.
  • Within cross-functional teams, build consensus and establish common ground with respect to regulatory challenges between Quality Assurance and Operations. Communicate actions, compliance gaps, and commitments to respective areas, including senior Quality leadership.
  • Interface with global partners and site leadership regarding quality issues, audits/inspections, and special projects.
  • Support global project teams and sites as needed.
  • Demonstrate flexibility to support global projects for sites within various time zones.
  • Support sites as requested to share and implement best practices within assigned project scope.
  • Stay current on evolving regulatory requirements related to GxP computer systems.
  • Develop and update global quality system documents.
  • Provide back-up support to team members.
  • Take on other duties/projects as assigned to support the Global Quality Compliance Team.

 

Knowledge, Skills, Abilities

  • Demonstrated ability to influence and lead professional staff in order to achieve goals, especially without direct positional authority.
  • Ability to evaluate and resolve complex technical problems.
  • Ability to drive functional, technical and operational excellence.
  • Strong knowledge of change management processes.
  • Working knowledge of computer system validation requirements and experience with GAMP 5.
  • Ability to communicate and develop an internal strategic network while working remotely.
  • Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
  • Strong written and verbal communication skills and effective presentation skills.
  • Self-motivated to sustain productivity in a remote working environment.

 

Physical Requirements

  • This position requires ability to work with computers.
  • Up to 25% domestic and/or international travel may be required.
  • Clear oral communication skills via Web-based conferencing.

 

Additional Information:

  • Bachelor’s Degree or higher in Science, Engineering or QA/Regulatory related course of study
  • Minimum of 7 years experience in a regulated industry with direct pharmaceutical experience in QA, QC or Regulatory Affairs
  • Experience with GxP computer system regulations (21CFR Part 11 and Annex 11) and GAMP 5
  • Working knowledge of GxP computer applications such as SAP, TrackWise, EDMS/Documentum, Maximo, EBRS, Sample Manager/LIMS, Empower, Chromeleon
  • Knowledge of business processes that the GxP Computer Systems Support (e.g., change management, document management, deviation investigation, CAPA, calibration, preventive maintenance)

 

What are the intangible skills you’d like to see?

  • Demonstrated ability to influence and lead professional staff in order to achieve goals.
  • Ability to evaluate and resolve complex technical problems.
  • Ability to drive functional, technical and operational excellence.
  • Strong knowledge of change management processes.
  • Working knowledge of computer system validation requirements and experience with GAMP 5.
  • Ability to communicate and develop an internal strategic network while working remotely.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Teams, etc.).
  • Strong written and verbal communication skills and effective presentation skills.
  • Flexibility to support global projects for sites within various timezones.



Qualifications



Additional Information

All your information will be kept confidential according to EEO guidelines.

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