QA Regulatory Officer
- Reference: JLS QARO
- Location: Cardiff
- Salary: £29000
- Type: Full time
- Start: ASAP
Just Life Sciences are seeking a Quality Assurance Regulatory professional who will be involved with
Ensuring the site site meets customer requirements for the manufacture and supply of Life Science products.
Coordinate the Group's regulatory query system ensuring positive outcomes
Support quality related investigations and continuous and improvement processes.
Qualifications, Skills and Experience
- Duty and responsibilities
- Work closely with the QA and Regulatory Affairs specialist which includes:
Preparation and hosting for Customer and ISO 9001 audits
Support with customer requests for statements and questionnaires
Participates in both group and cross-functional process improvement and development initiatives.
Quality related investigations and continuous improvements.
Performing audits to monitor compliance of internal operations, procedures and regulatory requirements via internal audits.
Support with Group's vendor management program including conducting audits.
Support with authoring, formatting and approving regulatory supports files.
Communicate and liaise with customers and sales as necessary.
Act as first line support and system administrator for the company’s electronic management system Q-Pulse; assists with development, implementation, and maintenance, as needed.
Troubleshoots existing practices and deviations using quality tools to solve day to day problems as they arise.
Participation in the change control process to ensure changes to processes, systems, equipment, and facilities are appropriately assessed and implemented
Required qualifications and experience
A scientific degree, or equivalent.
Minimum of 3 years’ experience in a global regulated environment with a sound understanding of quality system requirements. (cGMP and ISO9001 advantageous)
Must have software and technical skills, all Microsoft Office applications. (Q-Pulse or other electronic QMS software an advantage)
Internal Auditing experience to ISO9001 requirements (cGMP advantageous).
Confident and flexible working attitude; work effectively within an environment that has quickly changing priorities, and deadlines to satisfy customers both internal and external to the organisation.
Must be organised and possess excellent interpersonal and communication skills, with a good attention to detail.
Support development and maintenance activities of quality systems, reporting KPI’s; driving continual improvements and an understanding of commercial ‘Costs of Poor Quality’.
Interested then please email your CV to justyn at justlifesciences dot com
Just Life Sciences
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