Dr. Jürgen Henrich

Develop and maintain a group of SOPs to govern CSV on local site, in accordance with corporate policies and industry standards. Ensure that GMP-critical computer systems (business IT-applications, spreadsheets, analytical systems in QC, and automation systems in production) are implemented and operated on a sound compliant basis. Ensure awareness and training in these procedures throughout the site.

Responsible for the compliance of all local GxP-critical computerized systems (business IT-applications – incl. MES and ERP, spreadsheets, analytical systems in QC, and automation systems in production). Providing quality assurance expertise / guidance for computerized system validation, change control, testing, deviation management, and associated activities. Review and QA-approval of system life cycle documentation, and QA-release for operational use of all GxP-computerized systems.

QA Manager for CSV (e-Compliance) with QA oversight of all GxP CSV activities, incl. review and approval of the key validation documents. QA-Manager for the Document Management and eDMS System Owner. Providing training for e.g. GMP, Good Documentation Practice, Data Integrity, CSV, eDMS. Performing self-inspections. Subject Matter Expert for Information Security and SOX-compliance. People Management as head of the team „GxP-Document Management“

Project manager of the GMP-related bioengineered production of plant derived chemical drug compounds Project Supervisor according to § 6 (4) German law of genetic engineering

Head of process and quality management Drug Discovery Project Supervisor according to § 6 (4) German law of genetic engineering

Head of the department Internal Services (process management, service sequencing etc.) Leading and establishing of High Throughput-screening processes Development of unique cDNA-libraries for DNA-microarray Physical genome mapping Preparation of user requirement specification for process related LIMS-software to optimize lab processes

Biotechnology & Plant Breeding