CSV QA Key Expert

• Dec 2021 - Present

Senior III IT Validation Specialist

• Jul 2020 - Present

Roche Diabetes Care IT Quality and ValidationIn the position of Roche Diabetes Care IT Quality and Validation Specialist, responsible for delivery of Validation services for one of the key Business Partners. Managing a group of Validation Specialists, always focused on the highest standards and partner satisfaction. Taking part in the recruitment process, actively developing, knowledge sharing, coaching, and providing support to the team. Project allocation, demand management, and redistribution of duties and resources. As a part of the ITQV team, actively participating in the creation and streamlining of internal processes (SOPs, TOPs) and good practices. Evaluates the solution-related risk on many different levels and aspects (Patient-Related Risk, Technology Risk, Data Integrity, Security, Regulatory). Proven track record of knowledge and process transfer on the level of projects, teams, verticals, departments, and organizations. Experienced in governance standards, methodologies, frameworks as well as any medical device regulatory documentation.Good communication skills, good analytical and critical thinking, risk management and business acumen. Ability to work in interdisciplinary working groups aimed at implementing any Quality System. Committed to a job well done, proactive and special motivation to professional challenges.Conducting procedural trainings as well as quality consultancy for all business stakeholders. Show less

Senior II IT System Validator

• Oct 2019 - Jul 2020

Scope of role and responsibilities as above.

IT Professional - Validation Specialist

• Jan 2016 - Oct 2019

CSV IT Professional in Roche Global IT Solutions Centre.Taking the role of Clinical Operations Business Area Validation Lead, accountable for validation processes in all of the in-house managed systems in the Clinical Operations stream.In this Clinical portfolio, there were over 30 GxP systems (50 in total) both in their project or operational life cycle stages. Coordinating the work of 15+ Validation Specialists, supervising their job, streamlining and aligning approaches, providing consultancy and guidance. While providing support to a team of validation specialists, was responsible for oversight of validation activities across the entire product lifecycle. Assessing and defining the risk, and aligning validation strategies in order to meet regulatory requirements as well as ensure continuous audit readiness. A SPOC for all Clinical Operation Business Partners in the topic of Quality and Validation. Proven track record of managing validation process in major (3000k CHF) projects related to cross-organization LIMS implementation. Strong foundation in process improvements.At the same time performed the role of PMM trainer (internal Project Management Methodology) sharing knowledge and introducing company’s Project Managers and Delivery Managers into compliance aspects of Agile and Waterfall project methodologies. Show less

Computerized System Validation Specialist

• Jan 2015 - Jan 2016

Computerised System Validation Specialist in Roche Global IT Solutions Centre.Engaged in the area of Pharma Technical Operations, supporting manufacturing and laboratory systems in their implementation processes as well as operations, mostly managing validation activities for MES, LIMS, and ERP systems. During this time working in the multidisciplinary teams providing validation and risk evaluation expertise for the respective SMEs. Responsible end to end for the review and approval of all quality, validation, risk evaluation, and regulatory-related documentation. Always focused and responsible for compliance and audit readiness, yet streamlining processes, elimination of waste, and professes pragmatic approach. Most of the software implementation projects were led according to Agile methodologies which were increasing exposition to additional documentation and compliance challenges.- Ensure IT systems are securely operated and in compliance with pharmaceutical regulatory requirements,- Support & coach Incident/ Change / Problem / Knowledge Management Processes & IT System Key User Network- Identify risks by role, software, information type, and other categories and define acceptable and mitigation strategies,- Document and communicate the current state of the system,- Implement and monitor information security and regulatory requirements, policies, and compliance,- Assist with regulatory and data transfer procedures,- Assess IT system risks in relation to data, regulatory, business, patient, technology, processing confidential and critical data, system availability, supplier audit/assessment, corporate records management,- Determine the information security and privacy controls that should be implemented,- Document the controls that will be implemented by the project team or service organization and the residual risks found to be acceptable,- Analyse problems and deviations for/from business processes, transactions, data, and system functions, Show less

Quality Assurance Specialist

• Feb 2014 - Dec 2014

- Creating and maintaining laboratory procedures - SOPs, Guidelines, Manuals, Lab books,- Inspection readiness assurance,- Maintaining microbiology laboratory,- Laboratory procedures execution,- Laboratory quality systems maintenance,

QC Microbiologist

• Jun 2013 - Feb 2014

- Microbiology lab tests execution- Laboratory data base management- LIMS support