Lukasz Saluda
CQV Expert / Project Manager
Łódź
Summary
A specialist in manufacturing and production, capable of leading efficient teams and applying Lean manufacturing principles to reduce costs and increase process productivity. A versatile professional with experience in production supervision and quality assurance. In-depth knowledge of Good Manufacturing Practice (GMP) principles and requirements for production environments.
Overview
17
17
years of professional experience
3
3
years of post-secondary education
2
2
Languages
Work History
Project Manager
PQE Group
06.2024 - Current
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
TQ Senior Specialist / Senior Consultant
PQE Group
08.2022 - 12.2024
- Supporting external companies in the qualification processes of SAT, FAT, IQ, OQ, PQ for biomedical devices, production lines, process installations, computerized systems, gas collection systems (PA, N2, O2, CO2), cleanrooms, and water sampling systems
- Calibration of measuring devices
- Reviewing and developing SOP documentation
- Managing and coordinating resources and logistics for CQV projects
Equipment and Systems Qualification Specialist / Coordinator
Mabion S.A.
03.2021 - 05.2022
- Coordinating the work of the qualification team
- Creating qualification schedules in accordance with the VMP
- Preparing equipment qualification and service orders
- Developing qualification protocols and reports for biomedical devices
- Creating qualification instructions, device operation manuals, and new documentation, including VMP
- Conducting qualification of biomedical equipment, production lines, computerized systems, HVAC systems, and cleanrooms
- Supervising qualifications performed by external companies and reviewing and correcting their documentation
- Participating in management team meetings to improve communication and information exchange
- Engaging in various projects related to documentation updates and process improvements
Machine Setter
Henkel Loctite
08.2018 - 07.2020
- Preparing production lines for operation
- Reconfiguring machines and production lines
- Supervising the team operating the production lines
- Preparing orders
- Inspecting manufactured components for quality
- Maintaining quality and operational documentation
Senior Assembly Technician
West Pharmaceutical Services
10.2007 - 08.2018
- Preparing and performing manual and automated assembly operations of components and subassemblies
- Evaluating work for errors and discrepancies, making necessary corrections and modifications
- Creating project sequences and plans to improve operational efficiency
- Conducting meticulous inspections of components for cleanliness
- Reviewing and verifying that all work meets commercial orders and customer requirements
- Configuring and testing monitors and calculators, recording test data according to technical and quality specifications
- Completing and entering quality data reports, scrap reports, and improvement proposals
- Effectively managing tasks to meet project deadlines and production goals
- Conducting inspections and tests of electrical components, modules, and tools
- Collaborating with engineering, production, and accounting departments to ensure quality standards
- Planning, directing, coordinating, and assigning labor to meet production demands
- Training and advising employees to build a high-performance team
- Increasing efficiency and productivity by eliminating production constraints and reducing waste
- Overseeing production schedules, product quality, and on-time delivery
- Developing and implementing solutions to enhance quality, productivity, and cost reduction
- Working closely with the quality control department to manage product allocation
- Cooperating with engineers to adjust and modify production equipment
Education
Bachelor's Degree - Management
University of Social Sciences (Społeczna Akademia Nauk)
10.2021 - 06.2024
Skills
Project planning and development
Strategic planning
Risk management
Continuous improvement
Root-cause analysis
Timeline
Project Manager
PQE Group
06.2024 - Current
TQ Senior Specialist / Senior Consultant
PQE Group
08.2022 - 12.2024
Bachelor's Degree - Management
University of Social Sciences (Społeczna Akademia Nauk)
10.2021 - 06.2024
Equipment and Systems Qualification Specialist / Coordinator
Mabion S.A.
03.2021 - 05.2022
Machine Setter
Henkel Loctite
08.2018 - 07.2020
Senior Assembly Technician
West Pharmaceutical Services
10.2007 - 08.2018
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