The GAMP IRL Community of Practice (CoP) is a group of computer compliance practitioners who come together to promote the understanding of the regulation requirements governing the use of computer systems, control systems, and intelligent instruments, within the pharmaceutical industry. The GAMP CoP will co-operate with other ISPE Affiliates and/or CoPs in support of ISPE’s strategic direction, attract new members, especially Students or Young Professionals. Whenever possible, the GAMP CoP will form relationships, coordinated through ISPE, with like minded industry associations to share knowledge and best practices. The GAMP CoP will partner with suppliers to identify and share best practices in order to have a positive influence on the quality of computerized systems used in the pharmaceutical, biopharmaceutical, medical device, or other related industry.

Promote GAMP Standard and Best Practices to Pharmaceutical Industry and IT Suppliersand Provide Life Science Sector with knowledge about compliance implementation for newtechnology solutions in scope of IT. Organization of meetings and conferences including events with participation of internationalspeakers. Promotion of GAMP Publications and provision of a best practice forum

As the Director-Enterprise Quality-Program Management and Continuous Improvement has a global focus within Enterprise Quality owning the implementation and continuous improvement of the Quality Management System (QMS) and will lead the strategy, design, implementation, and establishment of benchmark sustaining mechanisms for the Enterprise QMS.Focus• Maintained a global focus within Enterprise Quality• Led the strategy, design, implementation, and continuous improvement of the Quality Management System• Established benchmark sustaining mechanisms for the Enterprise QMS• Implemented procedures and practices and developed SME and user communities• Supported audits and inspections, as appropriate• Scope included all associated documentation & IT systems aspects of the QMS across the Enterprise• Led a cross-functional team and governance committee • Proactively managed the scope, schedule, budget, and resources of the QMS Optimization program to ensure that the value of the program was delivered and documented• Created and owned a comprehensive change management system. • Provided guidance to Business Process Owners and Subject Matter Experts to ensure that enterprise-level requirements and interdependencies were integrated into each individual process and global standard

As an established IT Business Partner, assume responsibilities to drive the strategy, implementation and adoption of IT solutions to enable several critical needs 1) be the IT lead for the Global Quality function and 2) for all IT to lead the IT GxP Center of Excellence that provides delivery and support for virtually all the GxP applications and services across IT. As the Head for the GxP Center of Excellence the role involves leading a team that will provide Service Delivery Management/Managers, coordinated delivery of IT projects and support of GxP validated applications and services on behalf of all IT functional groups.Focus• Be the leading IT contact in the Quality response team when required as part of regulatory inspections – interface with Regulatory Agencies when requested by Global Quality• Provide and manage key services such as validation services requires as part of delivery and support of GxP projects• Shape demand for the Quality Systems aligned to the senior and executive business sponsors.• Developing IT strategy and maintaining a systems roadmap for Quality Systems aligned to the business objectives/requirements, • driving the implementation of the defined roadmap and obtaining the process, data and systems integration, compliance and efficiency required through a structured project methodology.• Communicate at Executive and Operational levels across Alexion.• Lead the selection of solutions across the IT platform • Drive new product/site acquisitions into the Global Business and Systems processes

An established IT Business Partner, shaping demand, developing and maintaining a systems roadmap for Quality Systems aligned to the business objectives/requirements. Driving the implementation of the defined roadmap and obtaining the process, data and systems integration, compliance and efficiency required through a structured project methodology.Focus • Shape demand for the Quality Systems aligned to the senior and executive business sponsors.• Develop an IT strategy aligned to the business Objectives• Develop a Quality Systems roadmap and drive its adoption / implementation• Deliver Quality Systems integrated into all other business processes in as seamless a fashion as possible.• Support the business in achieving its business and compliance objectives• Provide audit support for applications where appropriate• Develop Data Governance and Master Data Management processes with the business to ensure that all master data remains current and applicable.• Integrate Business “Super Users” for Quality systems. Ensure they are trained adequately and integrated with the Business Analysts.• Ability to interpret and create meticulously accurate business requirements so that the platform delivery teams can deliver on the defined requirements.• Lead the selection of solutions across the IT platform• Drive new product/site acquisitions into the Global Business and Systems processes• Communicate at Executive and Operational levels across Alexion.

Leading the Transition/Integration, IT Process Excellence & IT Data / Process Compliance organisation to implement consistent, standardised service delivery for Novartis TechOps/Quality IT (Manufacturing & Supply Chain) and Quality Assurance across the three Novartis divisions Pharma, Sandoz and AlconFocus:• Ensure global Novartis IT processes and tools used to support processes are fit for purpose, lean, cost effective and can be fully utilized by both internal teams, and service providers.• Ensures continuous processes & toolset feedback and improvement mechanisms are in place and effective.• Ensures that all new service offerings and associated processes are immediately on-boarded to the Global Service Delivery established processes and tools• Identify, analyze and propose improvements in global Novartis IT tools• Identify, analyze and implement improvements in internal processes• Ensure highest levels of compliance with internal and external regulations is achieved in all Global Service Delivery activities

Manage and develop the Application Management Service Framework and Support Service Delivery Methodology. Support the Application Management Organisation by ensuring global IT processes and tools are fit for purpose to achieve a first in class shared services organization with in GBS IT.Focus:• Develop and deliver application management support services. • Drive ongoing improvements and enhancements in service delivery performance.• Develop end to end application management service framework for global GxP applications.• Take ultimate responsibility for the quality of service and issue.• Develop the service strategy and guide continuous improvement efforts for the service (CSI)• Interacts with technology vendor to identify and evaluate new technology products• Develop knowledge management structure to facilitate knowledge sharing across groups.

Provide Laboratory Informatics technology administration and implementation services with a focus on leveraging the LabWare LIMS, Empower CDS Global Templates as well as ELN and SDMS solutions. Deliver effective software support services to Global Technical Operations (GTO) organizational units.Manage and support technologies that enable lean laboratory practices, reduce dependency on paper and connect global work teams and make collaboration easy. Also manage and support a platform that enables review by exception.

Manage and support IT Projects, Applications and Instrument Automation within the QC laboratory. Main focus on projects that enable lean laboratory practices, review by exception and provide a paperless lab solutions included Smartlab (LES) and CIMS (Consumable Inventory Management System). Manage and support additional projects and Computer System Validation within the QC laboratory to allow seamless integrating of the main laboratory systems to Smartlab (LES). Laboratory systems included OpenLAB (Agilents CDS system), Check Weigher, Camag TLC, FT-IR, UV, Balances, pH meters, Dissolution Baths, KF.Facilitated in other IT projects within Gerard Laboratories, including a successfully executed network upgrade project, disaster recovery project and successfully executed migration of the Gerard domain to the new Mylan domain.

Manage and support the OpenLAB Project (Agilent’s CDS system)Research ELN & LES systems and develop the chosen system Smartlab with the main focus on enabling lean laboratory practices, review by exception and providing a paperless lab solution. Develop Smart methods using method builder and instrument parsing techniques to allow seamless integration and quick deployment of the Smartlab system.Develop training documentation and SOP’s for computer system applications as well as computer system validation documentation in adherence to GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems. Also perform ongoing review of CSV status to identify project risks to improve our process and interfaces with team members to anticipate and manage changes to projects such as but not limited to, technical requirements, business requirements and schedule. Providing on-going support on all instrumentation and applications within the QC lab with the focus on resolving issues within applications where vendors fail.

Develop training documentation and SOP’s for laboratory instrumentation. Develop computer system validation documentation in adherence to GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systemsCarry out trouble shooting on HPLC, GC, laboratory instrumentation and laboratory applications on a daily basis.Calibrate and maintain laboratory instruments and Liaise with engineers to resolve on going system and application errors. Train end users in procedures within the laboratory and complete all relevant documentation for training files.

Carry out analytical testing on Raw Materials and Finished Products and also provide technical support as required by management.Report to the manager and write up deviation reports on testing or work practice.Assist the QC Supervisor in planning and scheduling the daily work of the analyst.

• General process activities including, Drug loading and examining Catheters/Stent. • Recording of Data. • Adherence to ISO standards and regulations in regards to Quality Control. • Operating within a clean room environment, providing valuable experience for future laboratory conditions. • Understanding and complying with external Auditors. Worked under pressure to achieve productivity targets.• Discarding of controlled drugs in compliance with IMB.