Artemis Pappas
Associate Director, Process Documentation Designer
- Role
- Associate Director, Process Documentation Designer, Center of Excellence Devops, Wrd at 辉瑞
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Artemis Pappas
Focused, self-managed with multi-disciplinary experience within the medical device and pharmaceutical industry.Advanced technical aptitude; ability to quickly learn and master new skills and process knowledge. Experienced in implementing software applications and global policies and procedures.Extensive training experience including application software, FDA Regulations, Infrastructure, Computer Validation, and other business process procedures.Excellent understanding of the following regulations: 21 CFR Part 11, GMP, GCP, GxP.Skilled project manager with thorough understanding of project management methodology.Skilled oral and written communications. Adept at communicating with all levels of management. Process and detail oriented with superior organizational skills.Innovative and determined with a career characterized by unwavering attention to detail and uncompromising commitment to excellence.Specialties: Bilingual: English and Greek.Proficient computer skills including Windows Project, Power Point, Access, Dreamweaver, Flowcharter, Visio, Publishing, S3, SAP, EDMS, GxPharma, NovaManage, LIMS, ELIS.Auditing and Investigative skills.Comprehensive understanding of CFR, ICH, cGMP, ISO Part 11.Experienced in Project Management.Six Sigma Green Belt Certification.Certification for Quality Assurance Authority for Computer Systems. Intercultural knowledge and global competency.
Experience
Associate Director, Process Documentation Designer, Center of Excellence Devops, Wrd
Oct 2009 — Present · Collegeville, PA, US
Collaborate with colleagues, customers, and stakeholders across the organization on projects relating to process enhancement and continuous improvement in the context of procedural documentation development (policies, standards and standard operating procedures) and contribute to compliance and inspection readiness strategies and plans.
Education
Villanova University
Certification, Six Sigma, Green Belt
2005 — 2005
Saint Joseph's University
Bachelor of Applied Science (BASc), Marketing and Finance
1986 — 1991
Skills
- Dreamweaver
- Iso 9000
- Project Management
- Visio
- Projects
- Lims
- Sap
- Validation
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- Six Sigma
- 21 Cfr Part 11
- Quality Assurance
- Regulatory Affairs
- Publishing
- Document Management
- Clinical Trials
- Access
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