Compliance Officer, Analytical Services Group - Oxford, United Kingdom - oxfordbiom

oxfordbiom
oxfordbiom
Verified Company
Oxford, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
We use science to save lives, and so can you.


We are currently recruiting for a Compliance Office to work as Compliance Scientist to join the Analytical Services Group team.


The purpose of this role (something about how role is not in Lab) is to maintain a high quality of analytical data and provide compliance support to the analytical team, effective management of quality records and continuously improvement of ASG processes in line with GxP requirements.

This is mainly desk-based which involves quality activities performed outside of the laboratory.


Our Analytical Services Group supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics.


Your responsibilities in this role would be:

  • Report writing of laboratory investigations
  • QC Checking of assay data in QC databases for data integrity
  • QC Checking of assays and equipment maintenance forms
  • Raising and completion of quality records (Deviations/Change Control/CAPA) in the time frame stipulated on relevant SOPs
  • Involved in internal audits and ensuring actions form findings are performed on time
  • Aid with setup and management of tools that facilitates the smooth running routine QC tests
  • Assist with the progression of departmental quality records in agreed timelines.
  • Management of selfinspections within the department, report findings and complete actions (where necessary).
  • Calculation checks for QC Release assays
  • QC checking of nontechnical assays
  • Monitoring monthly metrics to ensure the team maintains a high level of quality

We are looking for:


  • Science Graduate with a biological background or experience working within a pharmaceutical regulated environment
  • Understanding of GxP regulations
  • Understanding of the Quality Management System reporting structure and responsibilities within OXB
  • Knowledge of QC testing within a GMP environment
  • Computer literate (word, excel, MS Office)
  • Involved in internal audits and ensuring actions form findings are performed on time
  • Knowledge of writing concise quality records
  • Used Quality Management System like Qpulse (preferably)

About Us:

We are an innovative leading viral vector specialist focused on delivering life changing therapies to patients.


Our innovative solutions and proven expertise allow us and our customers, the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.


The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world's worst diseases and medical conditions.

We work together, motivated to make a difference, and so can you.


What's in it for you:


  • Highly competitive reward packages
  • Wellbeing programmes
  • Development opportunities
  • A 35hour working week
  • Welcoming, friendly, supportive colleagues
  • A diverse and inclusive working environment
  • Our values are: Deliver Innovation, Be Inspiring and Have Integrity
  • State of the art laboratory and manufacturing facilities
We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

**Collaborate. Contribute. Change lives

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