22 sep
|
3PBIOVIAN
|
Pamplona
22 sep
3PBIOVIAN
Pamplona
We are looking for a Head of QA (Audits, Inspections, Suppliers and Plant) to join our Quality Assurance Team.
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In this role, you will be responsible for managing, coordinating, and executing the company's internal audit program, supplier qualification activities, and compliance initiatives. You will play a key role in ensuring the Quality Management System remains compliant with GMP requirements and supports successful regulatory inspections, including FDA inspections.
Main Responsibilities:
As Head of QA (Audits, Inspections, Suppliers and Shop Floor), your responsibilities will include:
- Develop and execute the company's internal audit plan aligned with quality and compliance objectives.
- Lead and coordinate internal audits across the organization.
- Design and manage supplier qualification and monitoring programs.
- Execute supplier qualification audits and assessments.
- Monitor and analyze quality KPIs and performance indicators.
- Identify, investigate, and escalate GMP non-conformities when appropriate.
- Lead and support compliance improvement projects.
- Participate in regulatory inspections, customer audits, and mock inspections.
- Contribute to FDA inspection readiness and follow-up activities.
- Collaborate with cross-functional teams to ensure adherence to quality standards and regulatory requirements.
- Support company integration initiatives and quality improvement projects.
- Ensure effective implementation of corrective and preventive actions (CAPA).
Assessment Criteria:
- Bachelor's degree in Biology, Biochemistry, Chemistry, Pharmacy, or a related Life Sciences field.
- Master's degree in a relevant scientific discipline is highly desirable.
- 3-4 years of experience within a Quality Assurance environment in the pharmaceutical, biotech, or healthcare industry.
- Strong knowledge of G
📌 Head of QA (Pamplona)
🏢 3PBIOVIAN
📍 Pamplona