GVP Auditor: Elevate Pharmacovigilance Quality

CSL; Maidenhead; On-site; GBP 60,000 - 90,000; Full time

Job summary

CSL Seqirus seeks an experienced GVP Auditor to execute the global audit plan, assess safety data accuracy, and ensure regulatory and corporate compliance across external partners and internal safety functions.

You will identify findings, categorize risk, and collaborate with stakeholders to implement CAPAs that enhance PV system reliability. Strong analytical and cross-functional skills are essential.

Qualifications

• BS degree in a relevant biological science, pharmacy, or related discipline.
• Quality Assurance experience within a GVP-regulated environment.
• Auditing/inspection management experience in pharmacovigilance.

Responsibilities

• Audit execution of external pharmacovigilance vendors and internal safety processes.
• Develop and issue Audit Reports with risk-based CAPA recommendations.
• Identify non-compliance trends and communicate findings to management.
• Support SOP improvements and ensure compliance with EMA GVP and global/regional regulations.

Skills

Audit & inspection

Regulatory knowledge

Communication

Analytical thinking

Negotiation skills

Education

BS in biological science/pharmacy

Tools

EMA GVP Modules

Job description

CSL Seqirus seeks an experienced GVP Auditor to execute the global audit plan, assess safety data accuracy, and ensure regulatory and corporate compliance across external partners and internal safety functions.

You will identify findings, categorize risk, and collaborate with stakeholders to implement CAPAs that enhance PV system reliability. Strong analytical and cross-functional skills are essential.