Empresa: Michael Page
Provincia: Barcelona
Población: Barcelona
Descripción:
Perfil buscado (Hombre/Mujer)
The Validation and Compliance Manager will have the following requirements:
• Development of IT QMS infrastructure and data integrity approach by use of electronic records, digital signatures, blocked excel sheets….
• Leading the data integrity and qualification/validation of computerized systems according to Annex 11 of EU-GMP.
• Participate in root cause analysis investigation and execution of CAPA´s as part of OOS-OOT, Non-Conformities, Incidents, Complains under Warehouse and Computerized systems scope.
• Leading software management support related to Quality Activities in cooperation with assigned Quality Management System Compliance Manager.
• Leading and updating the integration of BMS (Building Management System), SAP, CCTV and Particles Size Monitoring software inside quality system.
• Preparation of all needed SOPs, WI´s and records evidence applied to Warehouse activities and computerized systems.
• Establishes Key Performance Indicators and provides product status reporting to the site management on product quality and compliance risks with proposed solutions for improvement of the quality and compliance systems
• Participate as an expert in software and warehouse premises for external and internal audits as well as for the inspections by regulatory authorities.
• Active support in Qualification Activities, SAT/FAT/IOPQ, Validation applied to Software´s and production, laboratory, warehouse and general core data center.
• Coordinate supplier audits during the qualification and validation phase focused on Computerized Systems and Warehouse/Manufacturing/laboratory, if needed.
• Participate as an expert in software and warehouse/manufacturing/laboratory premises for external and internal audits as well as for the inspections by regulatory authorities.
• Conducting of concerned trainings to the new staff inside Software Systems department under the Quality Assurance scope.
• Pharmaceutical company with new manufacturing facility in Barcelona|High added value project and development opportunities
The Validation and Compliance Manager must meet the following requirements:
• Master´s degree in engineering, pharmacy, biochemistry, biotechnology or chemistry.
• Postgraduate degree in IT-Systems could be an additional asset.
• Understanding of SAP management.
• Minimum 2 years of work experience in computerized systems environment for pharmaceutical premises which are under the EU-GMP certification, preferably in the aseptic production lines for vials and pre-filled syringes.
• Significant experience in Qualification, RandD and project management.
• Proven experience in EU-GMP and US-FDA inspections
• Good understanding of Annex 11 and Annex 15 of EU-GMP.
• Soft Skills:
• Proven ability to plan resources and manage priorities to consistently deliver on time against tight project deadlines
• Ability to work independently and to solve problems.
• Ability to effectively and clearly communicate into English and Spanish- both written and verbal.
• Good computer literacy skills in MS Office package as well PDF edition for creation or records.
• Flexible mind for work in a multinational, multitask and multiteam environment.
• Deep experience in the opening of a new manufacturing and RandD facility in Spain.
• Opportunity to develop the project from the very beginning.
• Competitive remuneration + additional bonus, according to the proven experience.
• Personal development plan according to the responsibilities and assigned targets.
• Flexible work schedule.
Tecnologías: BMS ,SAP ,
Tipo de Contrato:
Indefinido
Salario: Sin especificar
Experiencia: 2 años
Funciones: Ingenieros/Industria
Descubre más: https://www.tecnoempleo.com/validation-and-compliance-manager-barcelona/bms-sap/rf-1af215400267a35a244c
