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Quality Assurance (QA) Auditor GCP

Employer
Empatico
Location
London (Greater)
Salary
Excellent salary and benefits
Start date
17 Jan 2023
Closing date
16 Feb 2023

View more

Discipline
Clinical Research, Quality, Auditor, GCP, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

A global early phase CRO, this company is supportive, collaborative, and invested in long term development. A stable, healthy company, this CRO has big growth plans.

We are looking for a Quality Assurance (QA) Auditor in GCP.

Overall Job Purpose

Conduct audits of systems, processes, facilities, documents and studies within the company in order to deliver the audit programme as required by GCP. Ensure that the company is in compliance with the relevant SOPs, regulations and internationally recognised guidelines (including Statutory Instrument 2004 No. 1031 and its amendments, ICH GCP and GCP for laboratories).

Key Roles and Responsibilities

  • Plan and conduct assigned audits of the company's processes, systems, facilities, studies and documents including protocols, reports, computer system validation documents  in line with the annual audit programme and appropriate study audit plans to verify compliance and determine the effectiveness of the company’s quality systems and procedures with agreed timescales;
  • Plan and conduct assigned remote audits of low and medium risk suppliers and subcontractors.
  • Work cross functionally to follow up and close out audits including agreement of appropriateness of corrective actions to audit findings with relevant company staff.
  • Assess compliance with the company's Quality Management System (QMS) and ensure appropriate actions are agreed and effectively followed up;
  • Maintain an up-to-date knowledge of the current regulations, guidelines and company SOPs.

Skills and Requirements

  • Degree in Science or equivalent
  • Proven knowledge of Drug Development process
  • Excellent knowledge and experience of GCP and GCP for laboratories regulatory standards
  • Proven communication skills
  • Excellent attention to detail
  • Quality Assurance auditing and quality system experience
  • Experience in supporting regulatory inspections and client audits

#QA #QualityAssurance #QAAuditor #GCP #GCPAuditor #CRO #EarlyPhaseCRO 

BTH Recruitment are a boutique headhunting firm specialising in the Pharmaceutical and Clinical industry. Our core business focuses on small-medium sized life sciences businesses, sourcing and securing the highest calibre individuals in the market (i.e. you!). We pride ourselves on the consultative approach we take, supporting you to find the best next step for your career. Our friendly and professional approach is complimented by our in-depth industry knowledge and experience.

Company

We are a boutique, recruitment and selection company, specialising in three, bespoke offerings:

  • Executive retained search, where we will source, highly competent and fully screened candidates to fit your executive role perfectly;
  • Contingent recruitment where we will apply our significant experience and proven processes to produce a pre agreed number of qualified candidates for you to choose from;
  • Consultancy, where Empatico offers wide ranging HR and people management expertise, tapping in to our wide ranging and diverse associate talent pool, in order to provide you with the appropriate skills and experience to advise, guide and coach you towards your business goals and desired outcomes.

 

As our name would imply, our approach is to partner with our clients, over the long term, so that we are embedded in your business, understand your business drivers and challenges and are, therefore better able to source individuals that will fit with your culture and become high performers, over the long term.

Company info
Website
Telephone
02035877618
Location
1 Empire Mews
The Hideaway Workspace
London
Greater London
SW16 2BF
United Kingdom

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