Quality Assurance Assistant – Regulatory Affairs
E&O Laboratories Ltd., an employee ownership trust company, is a high growth microbiology culture media manufacturer, based in Central Scotland with two GMP facilities and a donor animal farm. We are seeking a Quality Assurance Assistant, specialising in Regulatory Affairs to join our busy and dynamic Quality team. This is an excellent opportunity for a person who enjoys working within quality management in a busy modern manufacturing environment.
This role involves assisting the Quality Manager with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.
- Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, IVD and other regulatory requirements.
- Act as Person responsible for regulatory compliance (PRRC) in accordance with article 15 of IVDR to ensure conformity of devices.
- Maintain regulatory databases ensuring product information is maintained.
- Take responsibility for promotion of regulatory awareness and awareness of customer requirements across the business.
- Assist with regulatory, customer and third-party audits of the business.
- Assist with the CAPA process ensuring actions are completed in line with business deadlines.
- Ensure approved suppliers and external providers files are updated.
- Assist with continuous improvement with regard to risk management and post market surveillance.
- Assist with the QMS documentation requests both internal and external.
- Prepare internal and external reports and collate data.
To be considered for the role, you must closely match the following criteria:
- Bachelor’s Degree in a related field is required and minimum 1 years’ experience in medical devices or IVD regulation or regulatory activities or minimum 4 years’ experience in medical devices or IVD regulation or regulatory activities.
- Knowledge of Quality Management systems, especially ISO 13485.
- Experienced user of MS Office suite.
- Strong written and oral communication skills
For more information, please see our website www.eolabs.com
To apply please email your CV and your salary expectations.
Production Operator – Westfield facility, Cumbernauld
E&O Laboratories Ltd is a high growth, employee-owned trust Microbiology Culture Media manufacturer, based in Central Scotland with two GMP facilities and a donor animal farm. We are recruiting Production Operators for their facility at Westfield, Cumbernauld.
Job Opportunity:
Successful candidates will work in our fast moving, high energy environment learning how to operate automated and semi-automated production lines, where good hygiene and attention to detail are essential.
Due to the working environment this role does require the wearing of full PPE including bodysuits, hairnets, facemasks and foot coverings, to protect the product and prevent potential contamination.
About you
To be successful in this role you must be a highly motivated individual that can demonstrate flexibility with a can-do attitude. You should be positive, productive, and proactive with a passion for teamwork and problem solving.
The ideal candidates will enjoy working as part of a small team, as well as having good literacy & numeracy skills, previous experience of working within a production environment may be an advantage.
Shift Patterns:
Mon to Thu 07.30 to 17.30 (40 hours per week)
Salary: £11.44 to £11.73 per hour