Manufacturing Administrator - Newcastle upon Tyne, United Kingdom - Immunodiagnostics System Ltd
Description
Manufacturing Administrator:
QA/RA - UK:
IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
IDS Boldon is the global IDS Headquarters occupying a single, multi-disciplined site.
The site focuses on the manufacture and distribution of manual Immunoassay products.
On site Purchasing, Logistics, Production, Quality Control and Process Development departments manage the supply chain, supported by local Sales Support, Quality Assurance, Regulatory Affairs and Finance departments.
As Group Headquarters, IDS Boldon also houses all head office functions.
In this role, you will be responsible for providing administration support to the Quality Assurance department, to ensure that our products are manufactured and distributed in accordance with the appropriate standards and regulations.
Principal Accountabilities
- Data entry and completion of administration tasks required to maintain the Quality Management System in line with regulations.
- Including the creation, maintenance and approval of all documentation
- Complete reviews of batch manufacturing records to ensure adherence to requirements
- Liaise with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to Production.
- Evaluate and continually improve Quality Systems to ensure that products and processes are up to date and meet defined quality standards
- Support the QA team with internal quality audits and assist with external audits
- Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints.
- Ensuring the promotion of quality awareness throughout the Company
- Release of quarantined materials
- Supplier/Distributor assessment, approval and reevaluation
- Review, approval and administration of Product Notifications
- Preparation of Post Market Surveillance Reports
- Administration of online training system
- Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs
- Assist with the preparation, execution and completion of validation documentation ensuring compliance to all relevant Quality Standards and Regulatory requirements.
Skills, Knowledge and Experience
Qualifications
- GCSE level or higher qualifications (OR at least 23 years relevant experience)
- Internal Auditor
Skills & Knowledge
- Good attention to detail
- Strong communication skills both internal and external
- Ability to work as part of a team, departmentally and interdepartmentally
- Ability to work under pressure and to strict deadlines
- Ability to work in an autonomous, selfmanaged role.
- Good organization and influencing skills
Experience
- At least 1 years' experience in a fast paced, administrative role within a manufacturing/production environment
- Knowledge of Quality Systems and their operation
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