Quagilance

GLOBAL PHARMACOVIGILANCE PV AUDITOR

Ejaz Butt, MRQA Hon FPIPA, has over 25 years of experience in the life science industry. From the NHS to Academic Research to Pharmaceutical industry experience.

Within the Pharmaceutical industry, Ejaz has purely specialized in Pharmacovigilance, with a strong foundation in PV Operational roles such as deputy QPPV, setting up and testing electronic submissions, and aggregate report authoring. Ejaz also has a specialist interest in the PV oversight of Patient Support Programmes and Market Research.

Ejaz has conducted around 100 audits both onsite and remote. Onsite audits were conducted in Europe, the Americas, Africa, the Middle East, and Asia.

Ejaz regularly attends conferences either as delegate, speaker or chair. Is an Honorary Fellowship Member of the Pharmaceutical Information and Pharmacovigilance Association, past President of PIPA and provided specialist QA training. He is also a member of the RQA and DIA, and has been part of the RQA Wales and West Forum committee, where he presented on Remote Auditing and PV Oversight of Market Research Programmes.

Quality Management

Supporting and developing the Quality System, including procedures, work instructions, and gap analysis.

Audit Programme Development

Managing and developing an audit risk assessment process, audit programme and mapping out the audit universe.

Inspection readiness support

Providing support for inspections, including scenario / role play, training etc.

Training

Developing and providing bespoke training.

Quagilance Ltd. Registered office: Suite A 82 James Carter Road, Mildenhall, Bury St. Edmunds, Suffolk, England, IP28 7DER

VAT registration: 457032600. Company registration number: 14533464. Website by SWA Design