Tomasz J. Email & Phone Number

Providing services to pharmaceutical companies (e.g. Roche/Genentech) as CSV Lead for entrusted systems.● Coordinating of validation effort to ensure completion of validation activities and inspection readiness for computerized systems with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation/Assurance (CSV/CSA) , Electronic Records and Electronic Signatures (ERES), Data Integrity (DI), especially with the EU Annex 11 / FDA 21CFR Part 11… Show more Providing services to pharmaceutical companies (e.g. Roche/Genentech) as CSV Lead for entrusted systems.● Coordinating of validation effort to ensure completion of validation activities and inspection readiness for computerized systems with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation/Assurance (CSV/CSA) , Electronic Records and Electronic Signatures (ERES), Data Integrity (DI), especially with the EU Annex 11 / FDA 21CFR Part 11, companies policies, SOPs and good practices (GxP, GAMP5),● Providing subject matter expertise to carry out validation activities for CS,● Participating- or leading in- QA/IT processes for entrusted systems: Change Management, Risk Management, Configuration Management, Incident/Problem Management, Backup & Restoration Management, ● Providing support during audits/inspections, ● Building of open communication channels with Team Members (BPOs, System Owners, Product Owners, BAs, Developers, Testing Teams) to share the CSV/CSA approach for effective gaining validation deliverable to complete project successfully and deliver final product to customer.● CSV training for newcomers.● Work with different tools: iRAAM/iRAAM+; ALM; ServiceNow; Jira; Gitlab; Allure/Selenium; EDMS: Veeva Quality Docs;● Experience with MyPMM and PMM Agile frameworks, Risk-based approach (Scripted- / Unscripted- / Exploratory Testing), Manual and Automated Testing. Show less

Pabianice, Pl [Validation Dept.]

Pharmaceutical solid dosage manufacturing site [Pabianice, Poland]● Creating qualification/validation documents across the Validation Life Cycle (Validation Plan, Protocols DQ,IQ,OQ,PQ, Incident/Deviation Reports, Validation Reports),● Conducting qualification activities for technological equipment and their computers’ systems (CSV) to establish/keep it in a state of compliance with GMP and related guidelines/regulations (GAMP5, EU Annex 11, FDA 21CFR Part 820, -Part… Show more Pharmaceutical solid dosage manufacturing site [Pabianice, Poland]● Creating qualification/validation documents across the Validation Life Cycle (Validation Plan, Protocols DQ,IQ,OQ,PQ, Incident/Deviation Reports, Validation Reports),● Conducting qualification activities for technological equipment and their computers’ systems (CSV) to establish/keep it in a state of compliance with GMP and related guidelines/regulations (GAMP5, EU Annex 11, FDA 21CFR Part 820, -Part 11),● Designing, implementing and developing of the qualification/validation strategy for technological equipment (Technological Equipment Qualification Master Plan) and for Packaging Validation,● Maintaining of the requalification schedule,● Participating in Quality Assurance processes: Change Controls, Risk Analysis, Deviations handling, CAPA, Audits/Inspections, Member of the FAT/SAT teams,● Performing trainings for personnel.Projects: Many projects in area of manufacturing site for solid dosage forms i.e. member of the R&D relocation project, serialization project for packaging validation of medicinal products, capacity extension project. Show less

Digital Factory, Customer Service Dept. [Poland]

● Commissioning, start-up and repairs of the low and medium voltage frequency converters and DC converters ● Resolving technical queries and preparation of offers, ● Trainings for customers.

Lek Sa, Sandoz Group Company, [Stryków, Pl]

Pharmaceutical solid dosage manufacturing site [Stryków, Poland]● Engineering supervision of technological equipment, scheduling of maintenance and calibrations activities,● Leading of repairs in a cooperation with technicians team and contractors, ensuring spare parts for entrusted property (SAP - SRM module),● Carrying out investigations in case of technical and/or technological problems.● Scheduling and performing qualification activities for the production machines… Show more Pharmaceutical solid dosage manufacturing site [Stryków, Poland]● Engineering supervision of technological equipment, scheduling of maintenance and calibrations activities,● Leading of repairs in a cooperation with technicians team and contractors, ensuring spare parts for entrusted property (SAP - SRM module),● Carrying out investigations in case of technical and/or technological problems.● Scheduling and performing qualification activities for the production machines, including their computers' systems, in compliance with EU Annex 15, Annex 11 / FDA (21CFR Part 820 and Part 11),● Designing, implementing and maintaining of SOPs,● Providing improvements to Quality Management System,● Team member of Lean Manufacturing- and the Factory’s Expansion Project, ● Team member of : User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Risk Analysis (FMEA), Site Acceptance Test (SAT), Qualification (IQ, OQ) and CAPA process,● Contributing to completion of milestones associated with specific projects, which results in keeping project on schedule,● Internal Auditor,● Training for production and maintenance personnel.Projects: Many projects in area of manufacturing site for solid dosage forms i.e. Capacity extension project (5B), Adaptation of technological equipment to the requirements of 21 CFR Part 11 (for FDA inspection), Lean Manufacturing for Granulation- and Tableting area, ATEX adaptation project etc. The winner of the contest for the biggest savings / cost avoidance for the site -2009/2010 edition. Show less

Lek Sa, Sandoz Group Company, [Stryków, Pl]

Pharmaceutical solid dosage manufacturing site [Stryków, Poland]● Commissioning and start-up/qualification tests execution (IQ, OQ) for a new production equipment and some minor infrastructural systems,● Cooperation with machines suppliers (technical/qualification aspects),● Performing repairs, ensuring spare parts,● Implementation of the GMP requirements into qualification and maintenance area for a new pharmaceutical plant:-Designing and executing routine equipment… Show more Pharmaceutical solid dosage manufacturing site [Stryków, Poland]● Commissioning and start-up/qualification tests execution (IQ, OQ) for a new production equipment and some minor infrastructural systems,● Cooperation with machines suppliers (technical/qualification aspects),● Performing repairs, ensuring spare parts,● Implementation of the GMP requirements into qualification and maintenance area for a new pharmaceutical plant:-Designing and executing routine equipment qualification activities, -Scheduling of requalification, maintenance and calibrations activities,-Designing, implementing and maintaining of SOPs, operating- and maintenance manuals. Show less

Work for LEK SA, Sandoz group company● Installation and commissioning of production machines in newly build pharmaceutical solid dosage manufacturing site

Lodz, Pl