Inspection & Audit Coordinator

4 semanas atrás

Lisboa, Portugal Buscojobs Portugal Tempo inteiro

Join Our Team of Enthusiasts
At KVALITO Consulting Group, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.
At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results-oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.
If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
Learn more about us at:
KVALITO Consulting Group
Inspection & Audit Coordinator
Position: KVALITO Consulting Group, Inspection & Audit Coordinator
Location: Remote, Barcelona, Spain
Type: Full-Time

Mission:
The core mission of the Inspection & Audit Coordinator is to ensure compliance with Good Practice (GxP) guidelines through meticulous coordination, documentation management, and logistical support for internal and external audits and inspections. This role is instrumental in supporting KVALITO's commitment to excellence and regulatory compliance across Biotech, Pharmaceutical, and Medical Devices in the Next-Gen Therapies. The Inspection & Audit Coordinator will work closely with cross-functional teams to uphold the highest standards of compliance and contribute to continuous quality improvement.

Key Accountabilities:
Audit & Inspection Coordination:
Support the 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.
Documentation & Record Management:
Ensure accurate and up-to-date documentation for all audit and inspection activities, following GxP guidelines and KVALITO's quality standards.
Generate and maintain detailed records of audit and inspection findings, preparing reports to provide operational insights.
Maintain compliance documentation, contributing to a streamlined and auditable record system.
Stakeholder Collaboration & Communication:
Act 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.
Facilitate communication with external stakeholders, including regulatory authorities, to ensure all parties are informed and aligned on audit timelines and requirements.
Support the logistics and preparation for regulatory authority inspections, ensuring compliance readiness.
Compliance & Continuous Improvement:
Regularly monitor and report on adherence to GxP guidelines, identifying areas for improvement and supporting the implementation of best practices.

Key Qualifications:
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.

Key Competencies:
Organizational Skills: Ability to manage complex scheduling and documentation requirements with precision.
Attention to Detail: High level of accuracy in documentation, ensuring all records comply with regulatory standards.
Adaptability: Ability to adjust priorities and work efficiently in a fast-paced, dynamic environment.
Problem-Solving: Skilled in identifying potential compliance risks and implementing practical solutions.
Relationship-Building: Effectively collaborates with both internal and external stakeholders to foster alignment and support compliance goals.

We offer great benefits:
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

Contact:
If you have the necessary background and experience and would like to join a team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including:
Your CV, cover letter, and supporting documents (diplomas, certificates, references)
Availability, including earliest start date
Salary expectations
Location preference

We look forward to your application.
Your KVALITO Team.

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