Computerized System Validation Manager

Bayer Türk Kimya Sanayii Ltd Şti

We are looking for a "Central of Excellence Computerized System Validation Manager"

WHO YOU ARE

• University degree in pharmacy, biochemistry, chemistry, engineering or related field.
• At least 5 years of CSV experience in Pharmaceutical Quality Management.
• Extensive practical experience in the validation of both global and local systems.
• Knowledge and good understanding of ©GMP requirements and relevant major guidelines (e.g. GAMP5, PIC/S - PI 011-3) for CSV.
• Extensive practical experience in the implementation of Data Integrity requirements into computerized systems.
• Knowledge and good understanding of Data Integrity requirements described in ©GMP and the relevant major guidelines (e.g. MHRA Guidance Document, FDA Guidance for Industry).
• Knowledge and good understanding of main business processes of quality management system.
• Good project management skills, knowledge and experience in global projects.
• Knowledge, practical application and understanding of the sciences/quality assurance are required to perform the functions of this position, including problem solving, troubleshooting and follow-up skills used in a pharmaceutical/GMP environment.
• Demonstrated ability to collaborate with others in cross-functional and international settings required.
• Demonstrated ability to communicate positively with personnel at all levels (verbally and in writing) is required.
• Demonstrated ability to take initiative and a willingness to learn and stay abreast of current standards required.
• Must have good personal computer skills and be quickly able to learn & adopt new computer skills. Good use of current Microsoft Office tools. SAP skills are preferred.
• Excellent command of both written and spoken English

YOUR ASK AND RESPONSIBILITIES

• To provide Validation Oversight over all country computerized systems throughout all phases of system life cycle according to the relevant Global SOPs. In order to achieve this goal, to develop and to manage an inventory of all GMP/GDP relevant systems used at country level.
• To contribute to the development of required Global Supplements & Master SOPs for Country Organization.
• To support and guide Country Quality departments for GxP Determination of systems at country level in order to identify GMP/GDP relevant systems and the validation need. To approve the outcome of GxP Determination.
• To perform feasibility assessment for software/system selection by analyzing the process and the requirements of country(s). To assess use of global systems or extension of already validated local solutions when possible to respond to need of country(s).
• To support Country Quality departments for performing Computerized System Validations throughout all phases of system life cycle in accordance with the relevant Global SOPs and Supplements. To perform required validation activities of PO/PM role on behalf of Country Quality in the case that Country Quality is the PO/PM of the system in question; specifically, to prepare all relevant validation documents and to conduct all required testing activities if possible.
• To ensure compliance for all GMP/GDP relevant systems. To give guidance to the responsible roles on follow-up processes for system life cycle. To ensure the application of Change Management for system changes and Deviation Management for system incidents in order to maintain validated status of systems.
• To plan and prioritize the projects which already exists or newly requested from countries depending on the country size/revenue and any risk to license (e.g. in case of an audit finding) in order to manage resources correctly.
• To serve as an expert in CSV for the country organizations in case that any guidance required.
• To explore and investigate the available global systems in Bayer in order to respond to common solution need of countries by enhancing the knowledge about global systems.
• To be responsible (e.g. as Local PM and/or Local SME) for the global systems which are provided centrally to countries. To perform all required validation activities for the roll-out of systems in order to make it available to countries. To manage the operational phase of systems (e.g. access right management) and to give end user support for the system use.
• To actively participate in IT Quality Community such as community calls in order to contribute to improvement of IT quality as an expert and to represent country quality perspective.