Quality Assurance - Eastleigh, United Kingdom - Novacyt Group

Tom O´Connor

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Tom O´Connor

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Description

Supporting the Primer Design Ltd Quality team responsible for the continuing improvement and maintenance of the Quality Management System (QMS) in compliance with all relevant standards identified by the company.

The QA Specialist will report directly to the Quality Manager and will support procedural and process improvements and changes.

In this role the individual will also be responsible for adherence to health and safety polices as well as other company wide procedures.


The post holder needs to be able to organise their own working day; prioritise their workload to meet departmental and company demands; take initiative, be proactive and have excellent attention to detail as well as have good communication skills.

The individual will need to be flexible, be able to work in a fast-paced environment and be able to meet set deadlines.

They must have a logical, pragmatic approach to problem solving


Required:
Experience of documentation control, batch release, Out of Specification (OOS), Change Control, Non-Conformances, Root cause analysis and CAPA. Knowledge of Good Documentation and Manufacturing Practice is also desired. Strong computer skills including Microsoft Office, and experience of using an e-QMS would be advantageous.

Main duties and responsibilities

  • Responsible for document management system(s)
  • Assure ongoing compliance with quality and industry regulatory requirements.
  • Assist the business to support the Quality management system in place.
  • Identify training needs and organise training interventions to meet quality standards.
  • Ensure the timely release of compliant, safe, functioning products through collaboration with all departments.
  • Document internal audits and other quality assurance activities
  • Provide guidance to achieve timely release of compliant products, leading to increased customer satisfaction and safety.
  • Investigate nonconformance issues and identify root cause and implementation of corrective and preventive actions.
  • Analyse data to monitor, identify trends and areas for improvement in the quality system.
  • Prepare reports to communicate outcomes of quality activities.
  • The completion of relevant QA activities deemed appropriate to the success of the Quality department.
  • Perform internal audits and supplier audits as required.
  • Support onsite audits conducted by external providers.

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