Empresa: Michael Page
Provincia: Barcelona
Población: Barcelona
Descripción:
Perfil buscado (Hombre/Mujer)
The QA Specialist will have the following responsibilities:
• Implementation of supplier qualification SOP.
• Performance of documental or presence audits according to the internal policies of the company.
• Keep up to date the supplier audit program according to the performed risk analysis.
• Create and/or review the performance of risk analysis studies for designated functions.
• Leading or participate in root cause analysis investigation and execution of CAPA´s as part of Non Conformities, Incidents, Complains under QMS scope.
• Participate in compliance improvement projects in concerned areas of the company.
• Preparation and review of Technical Quality Agreements
• Ensure compliance with standard work procedures, forms and work instructions that apply to all areas of the company.
• Draft, review and/or approve annual plans, standard work procedures and work instructions related to quality systems (QMS).
• Leading or participate in root cause analysis investigation and execution of CAPA´s as part of Non Conformities, Incidents, Complains under QMS scope.
• Supporting for the implementation and execution of internal Change Control´s.
• Training of staff in EU-GMP and US-GMP guidelines according to the approved annual program.
• Supporting the compliance and implementation of continuous improvement based think approach in cooperation with all company departments.
• Active participation in customer and internal audits, self-inspections and authorities inspections like AEMPS or US-FDA.
• Participate in the management and supervision of the company´s quality KPIs. Supporting in the elaboration of Quality Management Review.
• Pharmaceutical company with new manufacturing facility in Barcelona|Career opportunities and development.
The QA Specialist must meet the following requirements:
• Master´s degree in chemistry, pharmacy, chemical engineering, biochemistry or biotechnology.
• At least 1-2 years of work experience in quality assurance environment for pharmaceutical premises which are under the EU-GMP certification, preferably in the aseptic production lines for vials and pre-filled syringes.
• Proven experience in EU-GMP and/or US-FDA inspections, will be an asset.
• 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, SAP would be an asset, as well PDF edition for creation or records.
• Flexible mind for work in a multinational, multitask and multiteam environment.
In the purpose of international expansion, a consolidated and well-established pharmaceutical company decided to open a new manufacturing facility and RandD premises in the area of Barcelona. The main activities will be focused on acting as a Contract Manufacturing Organisation (CMO) for aseptic filling of generic and biosimilar products. Through the RandD premises, the company will also take the responsibility for importing Final Dosage Forms (FDF) inside EU markets from other third countries.
• Opportunity to develop the project from the very beginning.
• Competitive remuneration, according to the proven experience.
• Personal development plan according to the responsibilities and assigned targets.
Tecnologías: QA, testing
Tipo de Contrato:
Indefinido
Salario: Sin especificar
Experiencia: 1 año
Funciones: Tester
Descubre más: https://www.tecnoempleo.com/qa-specialist-barcelona/qa-testing/rf-1fe81593f2415371c649