CAPA Investigation Specialist

Search Consultancy

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,--York,York,

Key Skills :

CAPA, root cause analysis, GCP, medical device, pharmaceutical, clinical trials, clinical, regulator

Salary :


Date Posted :

17 May, 2017

Company Name :

Search Consultancy

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


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CAPA Investigation Specialist

I am currently supporting a leading and global clinical laboratory, which specialises in providing high quality central laboratory testing services designed to optimise clinical trial outcomes.

They are currently looking for an experienced and enthusiastic CAPA Investigation Specialist to join their busy and vibrant team. The successful candidate will be responsible for facilitating and performing investigations into issues arising within the laboratory, relating to clinical trials and diagnostic testing which may include; invalid assays or deviations, packaging, logistical and reporting issues.

The role:

* Manage closure of investigations within agreed timelines
* Perform/support conducting and documenting investigations with the use of root cause analysis tools such as, Ishikawa (Fishbone Diagram), 5 whys ect
* Support the implementation of CAPA resulting from investigations
* Gathers information including raw data and records to aid in the determination of the root cause of an event
* Lead and support cross-functional teams to identify root cause, evaluate technical client or patient impact
* Guides personnel in the investigation process including testing to prove the root cause of an event and collecting supporting evidence
* Writes/reviews investigation reports including, activities performed and conclusions drawn
* Support the re-analysis plan and re-test plan development
* Ensure corrective and preventive actions are appropriate and implemented as planned and that they have the intended effectiveness
* Identify recurring events and ensure appropriate actions are taken
* Communicate status of investigations and CAPA's to management
* Coordinate investigations and CAPA's with wider teams
* Act as primary lead at event meetings discussing the status of investigations
* Perform trending of root cause of investigations and issue reports to summarise

The candidate:

* The successful candidate will be educated to BSc in life sciences or related discipline
* Will carry a background in regulatory affairs, medical devices, clinical or pharmaceutical
* Will have a good understanding of GCP
* Candidates will need high attention to detail and strong communication skills with the ability to be versatile and adaptable

Key words:

CAPA, root cause analysis, GCP, medical device, pharmaceutical, clinical trials, clinical, regulatory affairs, QA, quality assurance, documentation

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Search Scientific, part of Search Consultancy is an Employment Business/Agency.

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.

Company Name:

Search Consultancy


Campbell House,215 West Campbell Street


Staffing Firms


United Kingdom





100 - 499





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