Qa Specialist

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 R&D 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 R&D 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.