Christopher Braun

About Christopher Braun

Experienced, knowledgeable, and results-focused QA professional with a proven track record of quality assurance initiatives, completing investigative reviews, and QA audits. Leader recognized for building strong working relationships to achieve organizational success.

Experience

1. Quality Assurance

   Novartis

   Sep 2018 — Present · Morris Plains, NJ, US

   QA Expert• QA oversight for several projects, including TechTransfer to bring site from single product to multi product• Validations including approval of protocols/reports/plans for Equipment/Utility/Area Qualificationo Real time support of operational issues to ensure minimal impact• QA Change Control SPOC for Asset and Product Changes, CR endorsement and coordination• Risk Management: QRA, FMEA used to justify risk / drive risk mitigation tasks• Work plan approval, coordination with Engineering/Facilities departments for facility modifications• Manage response / actions for Health Authority observation related to the Shop Floor, present response• Backroom coach for HA inspectionSenior QA GMP Officer• Approval of Major/Critical deviationso Use of Root Cause analysis tools and interviews to determine true RCo Driving cross-functional teams to identify appropriate CAPAs and prevent recurrenceo Critical event response, including real time containment actionso Product Disposition / Impact assessment approvalo Train QA team members in investigation and deviation writing, also deviation review/closure• Coordinated with project teams and Change Request coordinators for Gate approvals, QA CR assessment• Document review and approval• Contact for real time manufacturing issues, lead triage with QA Officers and Operations ManagementQA Shop Floor• Trained all members of the Shop Floor team on relevant QA programs• Lead or key contributor in creation or revision of several programs• Authored documents for QA programs, completed document reviews and approvals• Started the Human Error Reduction team to promote interaction between technicians/investigators/QA• Involved in the hiring process, conducted interviews, assisted with building the new SF team

Skills

• Sap
• Corrective and Preventive Action (Capa)
• Aseptic Processing
• Change Control
• Biotechnology
• Deviations
• Lims
• Laboratory
• Biopharmaceuticals
• Aseptic Technique
• Quality Assurance
• Trackwise
• Gmp
• Pharmaceutical Industry
• Sop
• Fda
• Pharmaceutics
• Vaccines
• Capa
• Standard Operating Procedure (Sop)