Audits and Quality Investigations Specialist - Pipeline

Location: Portugal, Serbia or India 

Contract: Till the end of 2026 with possible extension 

We are seeking a skilled professional with an auditing background to join the team of our client, specializing in CAPA, audits, and quality investigations. The ideal candidate will be adept at reviewing CAPA responses, addressing compliance issues, and investigating the root cause of quality concerns. A foundation in Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) is required. 

Key Responsibilities 

• Review and approve CAPA response plans.
• Facilitate quality deviations and compliance investigations.
• CAPA management documentation in ETQ system etc.
• Pull CAPA compliance metrics.
• Conduct audits and quality investigations aligned with regulatory standards (GVP, GCP).
• Investigate compliance issues and ensure corrective actions are implemented.
• Perform root cause analysis for quality events and non-compliance findings.
• Operate and improve systems for auditing and inspections.
• Compile and present audit findings and recommendations clearly and professionally.
• Work independently, managing workload and priorities effectively.
• Collaborate with cross-functional teams to support continuous improvement.
• Maintain detailed and organized documentation related to audits and investigations. 

Qualifications 

• 3-5 years of professional experience in quality assurance, auditing, or regulatory compliance.
• Strong knowledge of auditing practices and CAPA processes.
• Familiarity with Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP).
• Experience conducting investigations and root cause analyses.
• Excellent communication skills, both written and verbal.
• Demonstrated ability to work independently.
• Proficient with systems/software for auditing, inspections, and compliance tracking.