SEC Recruitment

Senior GxP Auditor

Location
Lausanne, Switzerland
Salary
Negotiable
Posted
10 Jun 2021
Closes
08 Jul 2021
Ref
127033
Contact
John Spring
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
Senior QA Auditor (GxP)

This position is offering a great opportunity for an experience compliance auditor to work for one of the fastest growing R&D divisions in the life sciences industry, within a revolutionary phase of this global organisation's business plans.

Salary & Benefits:

Full salary and benefits available upon request.

Role and responsibilities:

Leadership of quality compliance audits and oversights according to ISO Standards and various GxP disciplines including GMP, GCP, GCLP and quality management systems
Planning and execution of risk-based site review, establishing the annual audit programme
Identify risks and opportunities to the audited party and monitor and update the risk register in line with business evolution and audit feedback
Planning, execution and reporting of audits and facility inspections, raising any critical observations to the Quality Management division and ensuring that audit surveys are completed for each audit
Reviewing continuous improvement initiatives, providing support to Audit Coordinators and Lead Auditors. Reviewing and approving the CAPA plan, ensure timely audit / CAPA closure, and update the status in the programme
Supporting with the implementation of Quality Management System to ensure continuous improvement
Operate as a subject matter expert for the IT Systems definition & improvement used to support Audit process performance and related audit management systems


Requires skills and qualifications:

BSc or MSc in Technology / science / engineering or equivalent
Substantial experience in Pharmaceutical or Life Sciences, and of audit in GxP areasGood Knowledge of Quality Management System (QMS), IT systems supporting audit process performance and relevant quality standards (GLP, GCLP, GCP, ISO, GMP)
Lead Auditor certification in ISO9001, or ISO 17025, or ISO 13485, GMP or other relevant auditor certification would be a plus
Fluent in written and spoken English is required. French and other languages would be an advantage


To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650