Our client is a well-established medical device manufacturer based in the Kent area.
They are currently seeking to recruit a compliance Officer to assist the Quality Assurance / Regulatory Affairs Manager (QARAM) and other members of the quality team in day-to-day quality administration activities, essential to the smooth running of the Quality Management System. The role will be primarily office based with a focus on office related admin duties. The job holder may be required to perform other duties assigned by management from time to time.
Duties:
Responsible for all Quality Assurance production and packing related scanning, filing, collating, and controlling documentation relating to product release activities.
Responsible on behalf of Quality Assurance for assessing packing materials (approval for packing to start) and reviewing completed packing records daily / routinely for approval.
Maintain a document control system with input and guidance from the QARAM.
Maintain both physical and electronic filing systems to assist the QA and QC teams.
Scanning and archiving of records requiring retention. These documents would include batch history files, test results, quality agreements, etc.
Assist the QARAM in the creation and distribution of quality agreements, distributor agreements, supplier agreements, etc.
Typing up of meeting minutes, e.g., complaints meetings or regular quality meetings.
Inputting of data on MS SharePoint.
Assisting with the 'paper trail' element of complaint investigations.
Physical Filling and electronic filling of Quality management documents
Qualification and experience
- BTEC or BSc in science
- Experience in QA/ regulatory affairs
- Good computer skills: Entering and/or uploading data; trending results; Examples of software include Microsoft Word and Excel.
Previous experience of formatting documents and excel spreadsheets
- The successful candidate will have good communication skills, methodical and have good attention to detail.
To apply for this position, candidates must be living in the UK and eligible to work.