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Quality Assurance (QA) Auditor GCP

Employer
BTH Recruitment
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

BTH - logo

overview

BTH Recruitment was founded in 2014 with a vision of providing global strategic recruitment solutions to a select group of the pharmaceutical industry’s most exciting and innovative organisations. Seven years later, we have achieved this goal with a vigorous and unflinching focus on quality of service, and a delivery-focused, people centric approach that is authentic and engaging. 

Our recruitment service covers mid-level roles through to executive projects. Each project is tailored to ensure your role, team and business is being effectively marketed and communicated via the most engaging recruitment tools by our market-leading consultants. 
Our recruitment solutions focus on Retained/Executive Search, Interim and Freelance projects and Contingency.

We pride ourselves on our expertise, honesty and integrity.

our team

Ben Northfield
Managing Director. Account Director. Global Project Leader 
25 years business, management and consulting experience. 16 years recruitment experience dedicated to life sciences. Ben oversees and delivers global projects whilst also consulting with industry leaders on recruitment process, on-boarding, salary surveys, change management and succession planning

Yvonne Mallett
Senior Recruitment Consultant, Account Director
14 years recruitment and delivery experience, covering both in-house and boutique recruitment services. Yvonne has delivered projects for companies of all sizes from entry level through to Executive, of varying complexities, across Europe, the Americas and Asia Pacific

Rebecca Carmichael
Recruitment Consultant and Interims Manager

Rebecca brings a wealth of organisational, contracts and operational experience. She leads entry and mid-level projects across Europe, coordinates our large pool of freelance and interim projects, as well as supporting senior projects.

where can we support you

Over the last two years we have placed candidates in the following Continents:

Europe/EU - UK, France, Germany, Spain, Italy, Belgium, Netherlands, Austria, Switzerland, Poland, Greece, Georgia, Portugal, Ukraine, Moldova, Slovakia, Romania, Latvia, Czech,Bulgaria, Tunisia, Israel, Hungary,Turkey and Russia

USA - Boston, New York (Rochester, Manhattan, Syracuse), North Carolina, Alabama, California, Seattle, Maine, Denver, Florida, Tulsa, Louisiana, Cincinnati, Denver 

Asia Pacific - China, Australia, New Zealand, Inner/Outter Mongolia, Sri Lanka, Thailand, Philippines

South America - Mexico, Peru, Brazil, Colombia, Argentina

Scandinavia - Finland, Denmark, Sweden

Africa - South Africa

How Can We Help You?

Changing jobs or taking your career in a new direction can be a very daunting prospect. At BTH we develop long-term relationships by building an understanding of where you are in your career, how you got there and where you wish to go by providing you with ongoing career consulting and advice.

We are friendly, professional and methodical in our approach. Punctuality, honesty and transparency are central to our interaction with you. Our consultants will guide you on the structure of your CV and interview preparation, right through to offer negotiation, giving your notice and supporting you as you embark upon the next important step in your career.

 

testimonials

Neurology Consultant

I have known and worked with Ben and his team at BTH for many years now while I was at global CRO and most recently as a consultant for a leading AI/tech business. Ben identified and successfully recruited 2 very senior positions for us - and ensured that they were a good fit for this small vendor. These were made in a timely manner and actually all the proposed candidates could have fitted into these roles…it was much appreciated to have a choice of candidates!

Key to BTH successes is the fact that they know and fully understands the pharmaceutical industry landscape: from recruiting to the large, mid-sized and small Pharma’s, the biotechs, the CROs and the vendors (e.g. scales, imaging, ECG, labs etc). All these institutions have differing cultures, needs, roles and responsibilities - even for the same job title - and thus knowledge of these inherent differences by BTH really means that the recruitment process is much more targeted and streamlined to the appropriate candidate. We recruited an SVP Ops and Chief Commercial Officer really quickly - with a good selection of candidates even at these senior positions. Careful pre-interview assessment by BTH ensured that we only saw real candidates and, they also know a good number of these people personally thanks to the depth of experience in the business. This personal approach makes a huge difference and inspires confidence when you make senior, or other level, offers.

I consult for a number of other clients and will be approaching BTH when we start to recruit more fully for these global initiatives. I cannot recommend them more highly.

Non-Exec Director, Member of Supervisory Board, Independent Consultant

I first got to know Ben and his team when working as a consultant for growing tech business. They had selected Ben and his team as they stood out as a thorough, hard-working, very well connected group on previous searches for them. Ben’s delivery on two key searches I was involved in did not disappoint; his work was exceptional as were the appointments we made. BTH’s attention to the client and buy into the process was of a level I have rarely seen in my experience. I wouldn’t hesitate to recommend Ben and his team for any board or executive hires in the Life Science industry.

CEO of global CRO

I have worked with Ben and the BTH team whilst at three different organisations on a variety of Operations and Commercial roles. He has a good network and has always delivered on his commitments. We have hired some great candidates thanks to him and his team. Ben is also extremely responsive and provides regular feedback on the process. I would be happy to recommend him and BTH Recruitment to a colleague.

Find Us
Website
Telephone
02035877618
Location
1 Empire Mews
The Hideaway Workspace
London
Greater London
SW16 2BF
GB

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