Banu Refik Email & Phone Number

Netherlands

Netherlands

Basel, Ch

-Acting as a Project Quality Manager for the Antibody-Drug-Conjugate CAPEX project in Global Quality Engineering (GQE) department. -Responsible for the review and approval of C&Q Life cycle documents; -Responsible for the assessment, review and approval of quality records such as deviations, change controls, CAPAs, investigations, effectiveness checks, and extensions in line with valid SOPs related to the project. -Representing the Quality Assurance department in cross-functional teams and ensuring and managing interfaces to different internal and external stakeholder. -Supporting and participating in internal, customer audits and regulatory inspections. -Supporting continuous improvements programs to establish effective Quality Management Systems.

Basel, Ch

Acting as Quality support in the BioAtrium (Lonza-Sanofi consortium) Remediation Project for the SwissMedic Inspections. Supporting all quality related topics for the CQV Lifecycle Program for facility, equipment and utilities.

Basel, Ch

Project quality management responsibilities for the Global PI Data Historian Project.Data Historian is a key enabler for Lonza’s Go-Digital initiative. It is the link between different control systems and the data analytics platforms. The Site Data Historian Rollout project involves installation and validation of new site Data Historian System including interface from control system.

Basel, Ch

-Managing the CQV team regarding qualification and validation activities of computerized systems, equipment, facility and utilities. -Managing the Compliance team regarding Deviation, Change Management, CAPA, Document Management, and Investigations, Inspections Readiness as well as internal/external audits, inspections and product quality reviews, training.-Managing the Validation team regarding process, method and shipping validation.

-Project Management responsibilities for the GMP Startup Project to enhance the existing Kiadis production site (new Sanofi biotech site) into a GMP biotech production facility. -Work closely with project sponsor and stakeholders to complete project scope, goals, deliverables, resources, budget and timeline as well as validation life cycle deliverables. -Ensure that GMP project is delivered to meet customer expectations to the highest safety, environmental, quality, operational & performance standards.-Responsible for direct supervision of vendors/contractors during engineering works.-Provide leadership from QA as the intended source for QA leadership and support to Commissioning, Qualification and Validation life cycle activities related to facility, instruments, equipment, and processes. Includes oversight of validation plans, qualification protocols, and associated reports and procedures where applicable, as well as calibration/maintenance programs.-Provide appropriate support to technical investigations requiring complex root cause analysis and resolution efforts (i.e. CAPAs).

Beykoz, Istanbul, Tr

Brentford, Middlesex, Gb

Interface between the overall JV programme for Italy and China sites and responsible for Stakeholder Management, Project Planning, Budget Management, Supplier Management within the SLIMS project.

Basel, Baselstadt, Ch

Responsible for• Leading the global project compliance within Novartis Group. Responsible for end to end quality and compliance aspect of the project and validation deliverables for Track and Trace Systems globally.• Leading compliance of the track and trace systems during its lifecycle, with regards to Regulatory and Novartis Internal and global Standards. Perform document reviews & coordination of various activities including testing.• Providing GxP related validation expertise and Partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.). Create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.• Supervising and controlling validation process to ensure timely and cost-effective delivery of the system to the business users in each site.• Providing compliance & risk management guidance for IT, including the evaluation, implementation and monitoring of information security controls.• Acting as the first point of contact for all quality related queries on the track and trace projects, follow-up resolution of identified quality exposures and partner concern to line management if critical situations are not resolved in due course

Basel, Baselstadt, Ch

Responsible for• Leading the project compliance work streams. Responsible for end to end quality and compliance aspect of the project and validation deliverables for Track and Trace Systems• Leading compliance of the track and trace systems during its lifecycle, with regards to Regulatory and Novartis Internal Standards. Perform document reviews & coordination of various activities including testing.• Providing GxP related validation expertise and Partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.). Create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.• Supervising and controlling validation process to ensure timely and cost-effective delivery of the system to the business users. Identify and log issues found during validation execution, perform root-cause analysis to define corrective and preventive measures to be taken.• Providing compliance & risk management guidance for IT, including the evaluation, implementation and monitoring of information security controls.• Supporting Audits, Inspections and Assessments performed by internal and external agencies i.e. especially German Inspection. Evaluated the risks arising from control deficiencies, gaps and facilitates risk mitigation planning.• Acting as the first point of contact for all quality related queries on the track and trace projects, follow-up resolution of identified quality exposures and partner concern to line management if critical situations are not resolved in due course.

Brentford, Middlesex, Gb

Responsible for Stakeholder Management, Project Planning, Budget Management, Supplier Management.

Basel, Basel-Stadt, Ch

-Responsible for the management of Process Validation, Equipment Qualification, Computerized Systems Validation, Cleaning Validation and Utility Systems Validation.-Implemented all EU / FDA cGMP Regulations/Guidelines and Novartis Quality Requirements to newly established Sandoz Group. -Supported new projects as per GMP Compliance and Validation perspective. Projects involved: -Manufacturing Execution System (MES), GMP/HSE Upgrades for HVAC units; Syrup Production, Purified Water extension, and New Production/Laboratory Equipment installations.-Support GMP Compliance Department for Change Control, Deviations, Corrective and Preventive Actions, Complaints, Internal and External Audits. -Review Batch Records and cross check with registration for the new products.

Istanbul, Tr

Responsible for: -The management of Quality Assurance Department to bring systems into compliance with European and US Regulations.-The management of R&D, Quality Control Laboratories, Liquid/Solid Productions and utility systems to be validated according to Design/Installation/Operational and Performance Qualifications. -The management of J D Edwards (PeopleSoft) ERP computerized system validation project including the preparation of validation master plan, user requirement / functional specifications, design specifications for hardware, software, network, data migration, system integration and acceptance and also standard operating procedures for the information technology systems.-The management of process and system validation such as clean rooms, LAF units, pressurized gases, water systems. -Actively involved as a supervisor in the GMP compliance projects to comply systems with the EU regulations when Abdi İbrahim İlaç received EU permit in year 2004.

Aberdeen, Scotland, Gb

Responsible for process and project detailed engineering activities at: -Secondary pharmaceutical production facility for Roche Company, -Primary pharmaceutical production facility for Iodurated Contrast Media, Bracco Company, -10 MW Mobile Power Plant Project at Bilen Idil Company, -33 MW Combined Cycle project at Bilkent, -ISUZU Bus and Truck Plant Project.

Masters, Executive Mba

Bsc., Chemical Engineering

High School