|Discipline:||Quality Assurance, Regulatory Affairs|
|Salary:||£Salary: £60,000 - £75,000 Per annum - Depending on experience|
|Contact name:||Katie Dunbar|
|Published:||about 1 month ago|
|Expiry date:||13 June 2021|
Location: Remote work for UK based business
Our client provide top-level quality assurance and quality management consultancy services to the pharmaceutical industry.
With a range of specialism including GCP, PV and GLP, their current growth plans mean they are seeking a GCP expert, who brings prior experience working as an Audit Inspector for one of the regulatory authorities e.g., the MHRA or EMA.
The successful candidate 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 QMS and SOPs, 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.
Specific duties may include:
Performing the role of Project Lead, Lead Auditor, Client Contact, Co-auditor, or Consultant
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
Delivery of projects in compliance with agreed project proposals and budgetary constraints
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.
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)
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
Capability in conducting a range of service provider audits would be an advantage (e.g. biometrics, laboratory, phase I)
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
Confidence to work along or in team
Able to travel up to 30%, and ability to conduct audits remotely- can work independently in a home office setting
This is a great chance to join a highly respected QA consultancy with a great name in the market. The role is based working 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.
Salary: £60,000 - £75,000 Per annum - Depending on experience
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