Regulatory Compliance Specialist

Há 1 mês


Lisboa, Lisboa, Portugal Kvalito Ag Tempo inteiro

Transforming Quality and Compliance


KVALITO Consulting Group, a women-owned business founded in 2013, is dedicated to revolutionizing the life sciences and healthcare sectors through innovative solutions that prioritize quality and people.



About Us

We are driven by our vision to lead with talent and transform with purpose. Our mission is to empower high-performing individuals to reach their full potential while fostering lasting, high-value relationships with our clients.



Our Approach

We embrace diversity, equity, and inclusion in every aspect of our work, cultivating a results-oriented, ambitious, and caring culture. Our team is agile and adaptable, ready to learn and respond to evolving business needs.



Culture and Benefits

We offer great benefits including:



  • Flat hierarchies and responsibility from the beginning
  • People-oriented culture
  • Diversity and inclusion-focused environment
  • Global client projects in a multinational environment
  • Flexible working hours and home office
  • Involvement in global conferences
  • Individual professional development, training, and coaching
  • Unlimited full employment contract
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus


About the Role

The Inspection & Audit Coordinator plays a vital role in ensuring compliance with Good Practice (GxP) guidelines through meticulous coordination, documentation management, and logistical support for internal and external audits and inspections.


This position is instrumental in supporting KVALITO's commitment to excellence and regulatory compliance across Biotech, Pharmaceutical, and Medical Devices in the Next-Gen Therapies.



Key Responsibilities

The Inspection & Audit Coordinator will be responsible for:



  • Audit & Inspection Coordination: Supporting the audit and inspections department in planning and coordinating internal and external audits, ensuring all logistical aspects are well-organized.
  • Documentation & Record Management: Ensuring accurate and up-to-date documentation for all audit and inspection activities, following GxP guidelines and KVALITO's quality standards.
  • Stakeholder Collaboration & Communication: Acting as a primary contact for internal stakeholders, providing day-to-day support and ensuring smooth operations in relation to audits, CAPA plans, and inspection preparation.
  • Compliance & Continuous Improvement: Regularly monitoring and reporting on adherence to GxP guidelines, identifying areas for improvement and supporting the implementation of best practices.


Requirements

To succeed in this role, you will need:



  • Bachelor's degree in Life Sciences, Quality Management, or a related field.
  • Fluency in English (Written & Spoken).
  • Minimum of 3-4 years of experience in the Biotech, Pharmaceutical, or CRO environment with a focus on GxP compliance and operational support for audits and inspections.
  • Familiarity with GxP standards (GCP, GMP, GDP, GLP) and regulatory frameworks EMA, FDA, ICH.
  • Demonstrated ability to handle multiple projects and prioritize effectively in a fast-paced environment.
  • Proven experience working cross-functionally with internal teams and external stakeholders to achieve compliance goals.
  • Strong interpersonal and communication skills, with the ability to communicate audit and compliance requirements effectively.


$85,000 - $105,000 per year

Please send your application, including your CV, cover letter, and supporting documents, to facilitate further discussion about this exciting opportunity.



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