GCP Consultant

Our client provides professional, high calibre quality assurance and quality management services to the pharmaceutical industry. They currently seek three new members of their team who will deliver on a range of projects related 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.

Reporting to the EMEA Operations Manager, strong relationships will be built with clients, colleagues, service providers and professional bodies and regulatory authorities as necessary.

General Responsibilities

• Perform projects which fall within the job holder’s areas of expertise on behalf of client companies within the pharmaceutical industry

• Contribute to upskilling of consultants in the conduct of vendor and systems audits

• Actively participate in the Learning and Development System

• Manage assigned clients

• Assist with business development activities

• Perform other reasonable duties as requested by the job holder’s Line Manager

Duties will be carried out in accordance with the Quality Management System (QMS) including business and personal objectives as agreed during the annual performance appraisal process.

Specific duties may 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

• If qualified, performing the role of Mock Inspector and acting as subject matter expert to ensure effective inspection preparation management at both the Sponsor and Investigator Site

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

• Audit management, preparation, conduct, reporting, follow up and archiving/destruction 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

Consultants must maintain an up-to-date knowledge of international regulatory requirements and industry guidelines/best practices governing the pharmaceutical industry.

Essential Experience

• Confident in conducting and leading internal and external GCP audits for a variety of stakeholders
• Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage (e.g. MHRA, EMA)
• Capability in conducting a range of service provider audits would be an advantage (e.g. biometrics, laboratory, phase I)
• Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site
• Acting as subject matter expert to ensure effective inspection preparation management
• Expert knowledge of national and international GCP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided timeously
• Ability to identify issues and offer solutions in a pragmatic way
• Strong written and verbal communication skills
• Positivity, flexibility and adaptability
• Highly professional and self-motivated
• Ability to work independently in a home office setting
• Confidence to work along or in team
• Up to 30% travel and ability to conduct audits remotely

These roles are based from home, with travel to client sites as suitable post COVID. A generous salary and benefits package is on offer, including very flexible working hours, Time Off In Lieu (TOIL),  25 Days Annual leave, 8 Paid Public Holidays, health and life insurance, gym membership, extensive training and development and a pension scheme.

If you would like to discuss the roles in more detail please contact Katie Dunbar on +44 (0)1239 584300 or apply using the button and you will be called back.