GMP Auditor

My client are seeking a GMP Auditor to join their team, offering high quality, professional quality assurance, and quality management services to the pharmaceutical industry. Duties will be carried out in accordance with the Quality Management System (QMS) on behalf of an interesting variety of client companies within the biopharma or medical device industry- from big pharma to small start-up biotechs!

Projects may relate to any service offered to clients. This may include audits, preparation of training material and delivery of training, development of Quality Management Systems (QMS)/Standard Operating Procedures (SOP) and general consultancy.

Specific duties could include:

• Delivery of projects in compliance with agreed project proposals and budgetary constraints

• Performing the role of Project Lead, Lead Auditor, Client Contact, Co-auditor or Consultant

• Project management, including project plan preparation and archiving of project documents

• Audit management, preparation, conduct, reporting, follow up and archiving of audit documents

• Delivery of consultancy services (e.g. SOP development, quality system advice, general advice on regulatory compliance issues)

• Preparation of training material and training delivery

• Projects defined in SMART objectives

• Noncritical QC of project deliverables

• Assistance with the QMS e.g. document preparation and review, process improvement initiatives, internal and client audits, supplier audit programme

• Completion of timesheets and expense claims in a timely and accurate manner to ensure correct billing to clients

Working remotely from home or client’s offices, reporting to the Head of GMP Practice, daily basis interaction with other staff, clients/auditees, service providers. professional bodies and regulatory authorities.

All consultants must maintain an up-to-date knowledge of international regulatory requirements and industry guidelines/best practices governing the pharmaceutical, biotechnology, and medical device industries, so there are plenty of development opportunities to facilitate increasing competence and achieving your full potential. This will include:

• Participation in the process whereby knowledge and learning are shared across the organisation (i.e., by attending training meetings and presenting when requested)

• Maintaining competence records to provide evidence that individuals have the necessary education, training, experience and skills to perform their assigned tasks

• Attendance at external training courses

• Participation in ‘on-the job’ training, this may be either as a trainee or trainer

• Reading publications and other sources of literature, e.g. regulatory authority websites, CQA Advisor, QUASAR

This is a lovely company to work for, with a great team dynamic despite distanced working and a great reputation in the market. Please apply today to be considered and I will call to tell you more.