£35000 per annum, Benefits: 38 days holiday
+44 (0)151 666 8968
10 months ago
As soon as possible
Based in Liverpool
£35,000 full time equivalent – 0.5 FTE 17 hours total. Flexible hours and days.
Working from home initially
My client is an established research Laboratory based in the centre of Liverpool.
Due to growth they are looking to recruit a QA Officer on a part time basis to lead on GLP implementation and manage the QMS. The successful person will be employed on a 1 year Fixed Term Contract working 17 hours a week (0.5 FTE). The hours and days of work are completely flexible.
As the department expands there is scope to extend the contract for an additional 5 years or make the role permanent.
- The successful candidate will be responsible for helping to implement GLP across the department as part of expansion plans focussed on providing a wider service for their clients.
- The successful candidate will provide compliance support as well as being involved in project management and training of staff with responsibilities and supervision for GLP compliance.
- The successful candidate will have strong GLP experience with a Quality Assurance background ideally within an industrial environment – either Chemical or Pharmaceutical.
- Develop and implement / design of quality management systems within the department.
- Introduce new ways of working and new QA processes/systems.
- Take ownership of the quality management system, reviewing as required to relevant industry standards and implementation of new ways of working, driving to impact.
- Definition and co-ordination and carrying out audits, as defined by this schedule.
- Write and review Standard Operating Procedures (SOPs) as gap analysis dictates.
- Provide Quality Assurance and validation advice when setting up specifications/quality system documents.
- Employing risk assessments tools during decision making steps and be able to justify in writing these decisions
- Implement and operate a programme of supplier audit in liaison with the purchasing team and approval for raw materials for use in the department.
- Maintain a fully validated and compliant system to ensure:
- Document life-cycle management
- Physical and electronic archiving systems
- Planned document review process
- Robust change control system
- A system to support curation of archived documentation
- Testing deviation investigations and resulting CAPAs (Corrective Action, Preventative Actions) and complaint investigations are backed up by rigorous process
- Provide review, QA authorisation signature and audit all department generated client record sheets ensuring all documentation meets GLP (Good Laboratory Practice Standards).
- Train staff in GLP principles and audit readiness.
- BSc (Hons) in science based subject
- Experience with qualification and validation of plant equipment and processes, including writing and execution of protocols.
- Knowledge of health and safety regulations and legal requirements and ability to carry our risk assessments
- Challenging and investigating nature
- Excellent verbal & written communication skills, with the ability to communicate at all levels Numerate, with good working knowledge of Microsoft Office packages
- Knowledge and ability to carry out Internal auditing to aid compliance
- MHRA experience
- FDA experience is desirable
- Relevant experience of working within a research laboratory in a GLP/GMP testing environment
- Documentation controller/management experience and experience in quality assurance role in industrial/compliance based setting.
- Previous Quality Assurance role demonstrating ability to professionally challenge
- Ability to write reports for a variety of audiences
- Excellent presentation skills to policy makers in different contexts
- Ability to define new quality systems in compliance with regulatory requirements
- Ability to define auditing strategy
- Ability to contribute to up-skilling of current staff in new quality processes
- Flexible attitude to work, and excellent time management skills
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis (outside IR35 Determination). Agency PAYE and Umbrella engagement models are also available, which will result in a different pay rate than advertised above.
Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website.