Compliance Specialist

Há 4 dias


Lisboa, Lisboa, Portugal Kvalito Ag Tempo inteiro
About Kvalito Ag

Kvalito Ag is a women-owned business founded in 2013, dedicated to transforming the life sciences and healthcare sectors through innovative solutions that prioritize quality and people.

Job Summary

We are seeking an experienced Compliance Specialist to join our team. This role will ensure compliance with Good Practice (GxP) guidelines through meticulous coordination, documentation management, and logistical support for internal and external audits and inspections.

Key Responsibilities:
  • Support audit and inspections department in planning and coordinating internal and external audits, ensuring all logistical aspects are well-organized.
  • Collaborate with internal and external stakeholders to resource, schedule, and track timelines for audits and inspections.
  • Coordinate the creation, tracking, and closure of Corrective and Preventive Action (CAPA) Plans, maintaining strict adherence to timelines.
Requirements
  • 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.
Salary and Benefits

The estimated salary for this position is €60,000 - €80,000 per year, depending on experience. We offer great benefits, including flat hierarchies, responsibility from the beginning, people-oriented culture, diversity and inclusion-focused environment, global client projects, flexible working hours, home office, involvement in global conferences, individual professional development, training, and coaching.


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