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GCP QA Auditor

£Competitive + benefits | North West, Cheshire |  QA |  Permanent  | Ref:888521

Consultant

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Nadya Libecans

Which team do you work in? 

Drug Development

Which area do you specialise in?

Quality Control and Assurance

How do you keep up-to-date with the latest news in your sector?

I frequently read articles on changes and happenings in the industry, stay well connected on LinkedIn and regularly check in with relevant industry professionals.

What's your favourite film and why?

Honestly, I watch so many films it's difficult to pick just one, so for today I'm going to go with Mermaids because you can't go wrong with Cher!

If you could invent one thing what would it be?

Definitely would have to be heels that turn into flats so that I wouldn't have to carry two pairs of shoes everywhere anymore

What makes you #DistinctlyDifferent?

I believe knowledge is power and I strive to learn as much about people and the industry as possible to build lasting relationships and produce the best results for candidates and clients. 

More

The Role

GCP QA Auditor - CRO - Cheshire or home-based - £Competitive benefits

 

The Company

  • Privately owned global CRO providing support to the Pharmaceutical, Biotechnology and Medical Devices sectors

  • Have offices in the UK, Canada, Australia, Singapore and the USA and operate throughout Europe, North America, South America, India, China, Africa and Australasia.

  • Conduct clinical trials of all sizes with expertise in cell and gene therapies, orphan drugs, CNS and medical devices

  • Are a fast growing, dynamic company that offer invaluable experience, exceptional development and progression for employees

  • Competitive salary and benefits package

 

The Role

Our client is looking for an experience GCP Auditor to join their QA team in Cheshire or home-based if necessary. Responsibilities include;

  • Planning and scheduling of audits based on company audit program or as requested by a client organization

  • Completion of audits by visiting the relevant site(s), interviewing staff and reviewing documentation according to the applicable audit SOP/schedule

  • Categorizing and classifying the audit observations, formally reporting these and proposing effective and efficient corrective/preventative actions where applicable

  • Reviewing corrective actions/action plans suggested by auditees

  • Conducting follow up activities where required

  • Performing trend analyses on audits conducted

  • Liaise with company departmental heads to support implementation of business improvement initiatives

 

You

  • University/Bachelors' degree or local equivalent in medicine, science or equivalent degree/experience

  • Reporting of GCP investigator site audits within a CRO or pharmaceutical company (minimum 2 years)

  • Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.

  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients

  • Ability and willingness to travel 50% of the time (international and domestic)

  • Full, clean driver's licence

 

What should you do next?

This GCP QA Auditor role is one not to be missed; it encompasses the opportunity work for an exciting, forward thinking company! ……To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.



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