Job Description

This is a huge opportunity to learn from the best, develop as a quality profession al and fulfill your true potential. The team is a key interface across the various areas on site. Working within this team you will ensure documentation for the QMS is maintained as part of document control and control of records. The position requires a proficient communication and IT skills to support the site on the day to day administration of key quality documents.

• Ensure that general day to day activities such approval of manufacturing documentation, specifications and forms is complete in a timely manner.
• Responsible for maintaining the document control system by updating, reviewing and approving procedures and documents in line with change process.
• Support the team in batch release, certificates of analysis, reviewing of non-conformances, deviations, briefs and software
• Ensure the daily Tier board information is update and tracked
• Any other duties/projects as are reasonable and within the skills and ability of the post-holder.
• Ensure compliance and assist in the audits (pre audit and post audit follow up) to external (regulatory) requirements, including Quality Management Systems (ISO 13482:2016, MDSAP) and the In Vitro Diagnostics Regulations.
• Monitor supplier review, performance, specifications and failure investigations and update the QMS accordingly
• Add, monitor and flag overdue CAPA’s to the Quality Manager and department
• Assist in metric data for the Quality department.

Required Knowledge, Skills, and Abilities

• A-level or equivalent in Biological Sciences; related degree subject is desirable but not essential
• Competent in the use of the MS Office suite – required.
• Excellent communication skills, both verbal and written– required.
• High attention to detail and able to maintain accurate records. Ability to work independently and in a group setting with little direction or direct supervision.
• Work flexibly to ensure deadlines are met
• Experience with writing concise/accurate reports