Responsibilities:

• Maintenance and improvement of QM system in compliance with applicable GxP Guidelines and ISO 9001:2015.
• Facilitate a quality mindset and a culture of continuous improvement.
• Support commercial activity in-line with applicable quality requirements.

Tasks:

• Development and maintenance of quality procedures, standards and specifications.
• Define and implement methodologies for continuous improvement.
• Monitoring and development of the Quality Management System key performance indicators
• Manage quality complaints and deviations
• Management of Change Controls
• Coordinate technical support for commercial operations and regulatory competence centre.
• Perform supplier and customer qualification and performance evaluation
• Support inspections and perform internal and external audits.
• Management of Quality Technical Agreements
• Maintenance and overview of Risk Management
• Perform and maintain the GxP training system

Requirements:

• Minimum 3 years’ proven experience in Quality Assurance in the pharmaceutical industry or in similar functions in the past
• Effective communication skills and convincing personality
• Experience in delivering client-focused solutions based on stakeholder needs.
• Willingness to work in international teams
• Availability to travel
• Excellent verbal and written communications skills in English language, ideally also Spanish and / or Portuguese.
• Degree in Pharmacy, Chemistry, or related.

Detailed English CVs should be sent to: recruiting@helmportugal.com