650. Técnico Responsable de laboratorio farmacéutico (Qualified Person – QP)

Reiwa Healthcare S.L. (www.reiwahealthcare.eu) is a young Spanish pharmaceutical company (Laboratorio Titular de Autorizaciones de Comercialización) with Marketing Authorizations in Spain, Germany, Portugal and Hungary.

Reiwa Healthcare is also handling Medical Devices, Cosmetics and Food Supplements through its subsidiary Reiwa Nature S.L.

Job Summary

The Technical Director (QP) will manage all technical operations within the pharmaceutical company, ensuring that all manufacturing, packaging, and distribution processes comply with EU-GMP standards, Spanish regulations, and company quality standards. This position entails also the management of all technical operations related with Medical Devices, Cosmetics and Food Supplements.

As Qualified Person, this individual will be responsible for the release of medicinal products into the market, playing a critical role in maintaining the integrity, safety, and compliance of the company’s products.

Key Responsibilities

• Quality Assurance and Control
  • Set up and continuously improve GMP/GDP documentation and Quality system to meet regulatory and company standards.
  • Conduct and/or oversee self-inspections, as well as inspections by external regulatory bodies (e.g., AEMPS, EMA).
  • Implement corrective actions and preventative measures (CAPAs) based on audit and inspection findings.Product Release & Compliance.

• Product Release & Compliance
  • Act as the Qualified Person (QP), responsible for the final release of products manufactured or imported by the company in accordance with EU and Spanish regulations.
  • Ensure that each batch of medicinal product complies with EU-GMP guidelines, relevant regulatory requirements, and marketing authorization specifications before release.
  • Develop and maintain quality systems for batch release and control processes.
  • Decide on the final disposition of returned, rejected, recalled or falsified products.

• Regulatory Compliance
  • Ensure compliance with all relevant regulatory requirements, including EU directives, Spanish regulations, and international standards.
  • Collaborate with the Regulatory Affairs department to ensure that all product registrations and marketing authorizations are compliant and up-to-date.
  • Support preparation and submission of technical documentation required for regulatory filings.
  • Oversee the PHV system activities

• Technical Operations Management
  • Oversee the technical operations including manufacturing, packaging, quality control, and product development processes.
  • Lead troubleshooting efforts for any technical or operational issues, working with cross-functional teams to develop effective solutions.

• Staff Training and Development
  • Provide technical training to company staff and subcontractors to maintain compliance with GMP standards.
  • Establish training programs to ensure the staff is up-to-date on regulatory changes and industry best practices.

• Project Management
  • Collaborate with R&D, regulatory affairs, and production teams to ensure project timelines and objectives are met.
  • Participate in continuous improvement initiatives to enhance product quality, compliance, and operational efficiency.

• Supply Chain Support
  • Work closely with the Supply Chain and Logistics teams to ensure product availability and timely market release.
  • Provide technical support for procurement, supplier audits, and material selection to ensure compliance with GMP standards.

Qualifications and Skills

• Educational Background: Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific field. Must meet the qualifications for Qualified Person (QP) status as per EU directive.
• Experience: Minimum of 5 years in the pharmaceutical industry with at least 3 years in a QP or senior technical management role.
• Regulatory Knowledge: In-depth understanding of EU-GMP, Spanish regulatory requirements, and quality management systems.
• Technical Skills: Proficiency in quality systems, technical operations, and regulatory requirements for product release.
• Communication Skills: Excellent written and verbal communication skills in both Spanish and English.
• Attention to Detail: Strong attention to detail and commitment to quality and compliance.

Preferred Qualifications

• Experience with regulatory audits and inspections (AEMPS, EMA).
• Knowledge of product development, technical transfer, and supply chain processes within the pharmaceutical industry.
• Certification or advanced training in quality management systems (e.g., Six Sigma, ISO 9001)

Key Competencies

• Analytical Thinking: Ability to analyse complex issues, identify solutions, and make data-driven decisions.
• Problem Solving: Proactive approach to identifying issues and implementing corrective actions.
• Collaboration: Ability to work effectively with cross-functional teams and communicate clearly with stakeholders.
• Compliance-Oriented: A commitment to maintaining the highest levels of regulatory compliance and product integrity.
• Project Management: Strong project management skills with a track record of managing complex projects across multiple functions.

Benefits

• Competitive salary with performance-based incentives
• Professional development and continuing training opportunities
• Working flexibility with remote working most of the weekly days.