Senior GxP & CSV Consultant 1453320

Overview

Qualification: PhD in Biochemistry; Diploma in Biochemistry; Dipl.-Ing. Biochemical Engineering

Relevant Expertise: GxP Compliance, CSV, Equipment & Process Validation, GMP Manufacturing, URS / DQ / IQ / OQ / PQ, Data Integrity & Governance, Pharma Data Management, Audit Readiness, Automation & IT/OT, MES / PLC / SCADA, Data Analytics & AI

Strong GxP CSV & Validation Expertise with hands on experience in computerized systems equipment qualification and process validation
Deep Pharma Manufacturing & Automation Experience covering automated production systems aseptic filling skids environmental monitoring and SIMATIC PCS 7
End to End Qualification Lifecycle Knowledge across URS DQ IQ OQ PQ documentation review and audit readiness
Unique Combination of Science Quality & Data as PhD Biochemist and Biochemical Engineer with senior expertise in Pharma Data Integrity Data Management and Data Governance

CSV & GxP Compliance Consultant – Qualification Lifecycle & Pharma Data Management

Support of Computer System Validation activities within a regulated pharmaceutical environment
Support of audit-readiness activities and review of GxP relevant documentation
Review and support across the qualification/validation lifecycle covering URS, DQ, IQ/OQ/PQ and final reporting
Support in ensuring consistent lifecycle documentation and compliance
Optimization of pharmaceutical data management within the Document Management System
Close cross-functional collaboration with Automation, Engineering, Manufacturing, QA and IT/OT
Interface between technical, quality and digital stakeholders in the manufacturing environment

Quality Compliance Consultant – CSV, Equipment Qualification & Manufacturing Automation

Qualification and validation of computerized systems, equipment and manufacturing assets in production and laboratory environments
Validation/qualification activities for diverse skids, aseptic filling, laboratory chromatography systems and environmental monitoring
Creation and maintenance of qualification and validation documentation within the Quality Management System
Support during intensive qualification activities for new pharmaceutical manufacturing facilities
Contribution to the design, build and qualification phases during the scale-up of manufacturing capacity
Support of implementation and qualification/validation of SIMATIC PCS 7 in a greenfield environment
Work at the interface of pharmaceutical manufacturing, automation and quality compliance
Application of structured qualification and validation approaches within a highly regulated manufacturing environment

Project Manager – QC Laboratory Automation, CSV & System Validation

Implementation of cell-based assays within QC Analytical Development
Set-up and programming of automated liquid-handling platforms
Automation of high-throughput sample processing for quality control of recombinant antibodies
Qualification and validation of the overall automated system
Computer System Validation of the required software
Coordination and alignment between IT, Engineering, Quality and R&D
Combination of laboratory automation, scientific development and GxP compliance
Project management within a pharmaceutical QC and analytical development environment

Senior Manager Life Sciences – Pharma Data Integrity & Governance

Manager Data, Analytics & AI – Life Sciences Data Management & Governance

Member of the leadership team within the Data, Analytics & AI Practice
Focus on Life Sciences Data Management and Data Governance
Consulting at the interface of data, technology and Life Sciences
Management-level responsibility within the Data, Analytics & AI environment
Consulting within the Data, Analytics & AI Practice
Focus on Data Analytics and Data Engineering
Expansion of his pharmaceutical quality and scientific background into data-driven environments

Senior Consultant – Data Analytics & Data Engineering