Jan Kocma
GMP Consulting Expert
Experience
GMP Consulting Expert
AMW GmbH
- Project phases 1–9 in GMP consulting
- Advising and supporting investment projects in a regulated environment
Acting Senior Construction Manager
Sanofi
- Preparation for plant shutdown
- Taking over all phases from basic assessment, preliminary and detailed planning to approval and execution planning
- Construction supervision and concept for subcontractor management
- Developing the shutdown concept
- Project volume: €150M
Lead Construction Management & Project Control
Eurofins
- Construction supervision and project control in GMP construction
- Project phases 4–9
- Project volume: €7.9M
- Planning and overseeing pharmaceutical production facilities
Owner's Representative
BASF-Air Liquide Deutschland GmbH
- Construction of chemical plants and air separation units in the industrial gas sector
- Approval of pharmaceutical production facilities
- Project volume: €128M (phases 7–9)
- Project planning and coordination in industrial plant construction
Medical Technology Project Manager
Klinikum Region Hannover
- New ICU (intensive care unit) construction
- Tendering and project management for medical technology (phases 3–9)
- Quality management measures for DQ and IQ
Design Qualification (DQ)
University Hospital Frankfurt (Johann Wolfgang Goethe University)
- Construction project House 23 F in the GMP area
- Design and installation qualification (DQ, IQ)
- New pharmacy construction (work phase 9)
Project Manager Pharmacy
Heidelberg University
- IQ and pharmaceutical manufacturing processes
- Risk management according to EN 14971
- Work phases 1–9
Industrial Risk Management Representative
IMS
- Responsible for IMS in plant engineering in regulated environments
- Plant design and validation
Medical Technology Application Developer
Air Liquide
- Market development for medical devices in the DACH region
- Special systems for ultra-pure gases
- Market launch and CE-compliant systems for medical devices
- Adaptation of sales concepts
- Business development and customer process analysis
VOB/B Expert and Owner's Representative
Self-employed
- Acceptance tests according to VOB/B and expert services
- Project management for public clients (work phases 5–9)
- Owner's representation and construction supervision
- Review of contract documents and cost control
- Interface management
DQ/IQ Specialist for Pharmaceutical Manufacturing
State Construction Management Hanover
- Design and Installation Qualification (DQ, IQ)
- Risk assessment and validation of pharmaceutical facilities
- Project phases 6–8
- Contract volume: €15 M
Business Development
Linde Gas Therapeutics (Linde Group)
- Business development in the services and investment market environment
- Marketing Europe and REC organization
- Strategic positioning and business development
- Lead Auditor for QI risk projects
- Construction and project management EMEA
- Direct reporting to the European CEO
- Contract volume: €120 M p.a.
Industry Experience
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Experienced in Pharmaceutical, Construction, Healthcare, Chemical, and Biotechnology.
Business Area Experience
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Experienced in Quality Assurance, Project Management, Procurement, Marketing, Product Development, and Strategy.
Skills
Plant Engineering And Pharmaceutical Production.
Industrial Construction, Special Installations And Medical Technology.
Technical Pressure Systems For High Purity Gas Technology Up To 7.0.
Gmp Investment Projects, Site Supervision, Project Planning.
Coordination And Organization Of Structural And Civil Works, Labs And Clean Rooms.
Designing And Overseeing Construction Plans To Meet Planned Timelines.
Monitoring Progress And Calculating Costs For Construction Sites.
Coordinating Official Inspections And Approvals.
Recruiting Staff For Construction Sites.
Coordinating And Procuring Materials For Construction Sites.
Documentation Related To Construction Sites (E.g., Defect Reports).
Implementing And Ensuring Compliance With Safety Aspects, E.g. Occupational Safety, Health And Environmental Issues.
Operating Safety Ordinance (Betrsichv) For Pressure Equipment, Qualified Person For Pressure Vessels And Pipelines According To Annex 2, Section 4, No. 3.
Final Testing, Handover To Operator And Acceptance Of Pharmaceutical Equipment.
Liaising With Authorities On Approvals And Deviations As Part Of Optimized Quality Management.
Large-scale Projects Phases 1-9.
Specialization In Gmp Approvals, Especially Qualification And Requalification, Construction Scheduling, Feasibility Studies, And Tenders.
Medical Technology, Expert In Medical Equipment Construction.
Fmea, Plant Engineering, Electrical Engineering, Leadership Experience Across The Entire Value Chain, Specialized Knowledge In Tendering/contract Awarding Under Vol/vob.
Building Services, Site Management, Medical Technology Equipment, And Process Engineering.
Plant Technology, Piping Construction, Compressor Systems Up To 7.0 Purity.
Iso 8573 Et Seq. Compressed Air Systems Up To Class 1.1.1.
Ce Coordination For Medical Devices.
Industrial Project Planning, Public Institutions.
System Audits Including Supplier Audits.
Ensuring Quality Management System Compliance With Standards Such As Iso 13485, Mdd, Mdr, Iso 7396 Et Seq.
Process Audits, Product Audits.
Risk Assessments According To Betrsichv For Pressure-related Hazards.
Plant Engineering Hoai Project Phases 1-9.
Gmp Manufacturing And Engineering.
Iq-fmea.
Executive Management.
Project Management For Large Projects.
Operating Safety Ordinance (Betrsichv), Trbs Etc., Trgs Etc.
Risk Assessment And Analysis According To Iso 14971 Etc. And Iso 31000 Etc.
Hoai, Vob, Vof, Vol.
Construction Process Control.
Languages
Education
Master · Business Psychology, Applied Engineering Psychology
Industrial Engineering
Industrial Foreman
Certifications & licenses
Auditor ISO 13485
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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