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Senior Quality Assurance Officer

Employer
CK Group
Location
Cambridgeshire
Salary
Competitive
Closing date
18 Jul 2024

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Sector
Chemistry
Contract Type
Permanent
Hours
Full Time

Job Details

We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join a Quality Assurance team.


Company Information:
Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. They provide leading support to the development of complex, breakthrough therapies for a globally diverse market and are at the forefront of revolutionary medicine in which life-threatening diseases are treated. 


Job Summary:

The Senior QA Officer, will be responsible for overseeing and ensuring compliance with relevant regulatory requirements and quality standards throughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products. 
This role will take the lead on developing and implementing quality assurance systems overseeing the management of quality records (change controls, non-conformances deviations), including PQS wording. The Senior QA officer will work closely with cross functional teams to drive continuous improvement, ensuring all records are completed, monitored and reviewed in a timely manner.


Key responsibilities will include:
  • Monitor and ensure compliance with relevant regulatory frameworks (GMP, GDP).
  • Develop and maintain quality management system documentation including policies and procedures.
  • Provide support to the QA Manager to ensure that any quality record is assigned to a QA representative, and that stages are completed in a timely manner.
  • Manage and supervise a team of quality assurance professionals.
  • Participate in risk assessments and develop strategist for risk mitigation.
  • Identify areas for improvement and implement effective quality control measures.
  • Ensure effective communication with all stakeholders.
  • Ensuring all our suppliers meet our Company’s high standards for quality and compliance.
  • Leading and participating in QMS initiatives.

The successful candidate will have the following experience/qualifications:
  • BSc or MSc in a life science subject or comparable experience.
  • Significant experience of working in quality assurance within the pharmaceutical or biotechnology industry, in a GMP compliant environment.
  • Experience of performing external and internal audits.
  • Strong communication skills, attention to detail and the ability to work collaboratively with cross functional teams.
  • Comprehensive knowledge of regulations and quality standards relating to ATMPs.
 
This is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.
 

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 101925 in all correspondence.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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