Senior GxP & CSV Consultant

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

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

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

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 consulting role within the Pharma R&D – Data, Analytics & AI Practice

Focus on Pharma Data Integrity and Data Governance

Application of data-management expertise within Life Sciences environments

Combination of scientific, regulatory and data-oriented perspectives

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

Consulting within the Quality Compliance Practice

Computer System Validation

Process Validation

Equipment Qualification

Automation within pharmaceutical manufacturing

Support of regulated Life Sciences manufacturing environments