Senior Quality Officer (QEs and CAPAs) Lisboa

Senior Quality Officer (QEs and CAPAs)
Lisboa
Lisboa, Lisboa, Portugal

Company Description

We are Prime
Vigilance (part of Ergomed Group), a specialised
- size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Prime
Vigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining
- term relationships and becoming a global leader in our fields. We cover all therapy areas, including medical devices.

We invest in our staff through excellent training and development opportunities. We value employee experience,
- being, and mental health, recognizing that a healthy
- life balance is essential for satisfaction and
- quality client service.

Join us on this exciting journey to make a positive impact on patients' lives.

Job Description

The Senior Quality Management Officer ensures that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed accurately, timely, and in compliance with global regulations, legislation, and Prime
Vigilance standards.

Responsibilities:

1. Lead administration, tracking, and management of QEs and CAPAs at Prime
   Vigilance.
2. Coordinate root cause investigation meetings and support Subject Matter Experts in conducting root cause analysis.
3. Manage QEs and CAPAs workflow.
4. Support operations as a subject matter expert on QEs and CAPAs management processes.
5. Participate in process optimization and continuous improvement initiatives.
6. Oversee timely completion of action items (CAPA and effectiveness checks) for US projects.
7. Participate in audits and inspections as a QE and CAPA SME.
8. Provide training and coaching to operations and junior team members on Quality Management.
9. Assist in trending deviations data across the company.
10. Perform peer reviews of QE work.
11. Respond to audit findings and requests.

Qualifications:

• University degree in Biomedical Sciences, Natural Sciences, or Health Sciences.
• Relevant experience in a Quality and/or Compliance role.
• Experience in Pharmacovigilance, Medical Information, or Medical Devices.
• Experience with electronic Quality Management Systems is desirable.

Additional Information

We promote diversity, equity, and inclusion by fostering an equal opportunities workplace and a
- centric environment where everyone can contribute and grow.

We believe in a
- first approach, valuing our people as our greatest strength, which drives our success in improving lives.

We offer:

• Internal training and career development opportunities.
• Focus on personal and professional growth.
• A friendly, supportive environment.
• Opportunities to collaborate globally, with English as the company language.

Our core values:

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to your application.