Niran Perera Email & Phone Number

Brentford, Middlesex, Gb

Slough, Berkshire, Gb

- CSV lead for the implementation and validation of a company wide SAP ERP system covering 120 sites around the world and multiple business functions including Manufacturing (Production, QC, QA, Warehouse etc), Procurement, Logistics and Finance- Responsible for the development and implementation of a global and site specific validation/qualification strategy for the core ERP modules and supporting systems including Master Data Management, Quality Management, Solution Manager, SAP Infrastructure and other associated third party software such as HP Quality Centre for automated testing- Provide direct guidance and support to the Global and site SAP teams- Management of all validation activities for the SAP programme including financial and human resource planning- Assessment of third party SAP service providers

Slough, Berkshire, Gb

- European lead for a team responsible for strategic direction and quality oversight of CSV processes and activities for the Global and European Businesses- Ensured that Software Development Life Cycle (SDLC) and CSV practices are employed to enable validated, compliant and business effective computerised systems for manufacturing, laboratories and other regulated functions - Provided direct guidance and support to the company’s IT organisation for multi-site solutions- Management of validation projects for IT systems and validation consultants- Development of in-house computer system validation procedures- Providing coordination and CSV support during regulatory/customer audits for Europe- Full life cycle validation (21CFR Part11/GAMP5) of in house developed IT systems/third party IT systems, including writing/reviewing of Site Master Plans, System Validation Plans, Project Plans, User Requirements Specification, Installation/Operational/Performance Qualification Test Scripts and Reports, Validation Summary Reports and execution of Test Scripts- Validation of IT infrastructure / Data centres with respect to GxP and validation requirements and apply the appropriate validation strategies

Gb

- Development of a risk based computer systems validation strategy and SOP`s to meet latest industry guidelines- Review existing systems and IT infrastructure with respect to GxP and validation requirements and apply the appropriate validation strategies- Liaise with internal software developers and external contractors to ensure the software is delivered in a validatable manner- Perform full life cycle validation (21CFR Part11/GAMP5) of in house developed IT systems, including writing System Validation Plans, Project Plans, User Requirements Specification, Installation/Operational/Performance Qualification Test Scripts and Reports, Validation Summary Reports and execution of Test Scripts- Validation of external IT systems to meet company, regulatory and industry standards- Project manage computer system validation projects- Responsible for Test managing during critical validation phases to ensure compliance with company procedures- Experience in the validation of a wide range of systems including: -Electronic submission system for clinical trial data to regulatory authorities -Custom Image and Data Management systems used for clinical trials -HPLC systems -Capillary Electrophoresis systems -Temperature Monitoring systems -Temperature mapping systems -Excel spreadsheets used for GxP purposes

Milford, Ma, Us

QC Senior Analyst/LIMS AdministratorLIMS / ITo Responsible for the Implementation and validation of a new LIMS o Certified LIMS administratoro Programming in LIMS Basic/SQL/HTMLo Design and Development of Crystal Reportso Development and validation of analytical spreadsheets using Microsoft Excelo Trending and data analysis of Microbiological dataMicrobiology/ Development Microbiologyo Microbial analysis and identification of environmental and utility sampleso Environmental and water monitoring of clean roomso Microbial identification using traditional and rapid methodso Sterility control and working to cGMP to ensure compliance with latest international regulationso Bioburden and sterility testing of final product samples to USP specificationso Kinetic Chromogenic and Turbidimetric LAL testing o Manufacture and testing of Microbial Cell Bankso Method Development and Validation/Verification of microbiological methodso Laboratory equipment validation (DQ, URS, IQ, OQ) and subsequent staff training in new instruments o Liaising with new customers, project managers and QA personnel with regard to QC microbiological methods and issueso Performing technology transfers from R&D and new customers to Avecia QCo Experience in auditing external contract laboratories