Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and GoodManufacturingPractice (GMP). The successful applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and GoodManufacturingPractice (GMP). Deputise for Senior Quality Systems Engineer when required, to ensure progression of departmental commitments. We are looking for someone who has: Minimum A level … Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and MRP Knowledge of GMP and audits Ability to work with minimal supervision and use initiative. Good interpersonal skills and the ability to communicate well in English both written and more »
the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and GoodManufacturingPractice (GMP). • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and GoodManufacturingPractice (GMP). • Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook. • All other essential duties as directed more »
processes adhere to quality standards and regulatory guidelines. Requirements: High School Diploma or Equivalent qualifications to meet the demands of document control in a GMP-compliant manufacturing environment, such as a pharmaceutical or biotechnology facility. Certifications related to document control, quality management systems, or regulatory compliance 5+ Years of Experience … and other relevant tools Attention to detail and accuracy are essential for ensuring the integrity and compliance of documentation. Familiarity with GoodManufacturing Practices (GMP) or other relevant regulatory standards If you have experience in CQV, Doc Control, Turnover, Clean Utilities, Process Engineering, Documentation, HVAC, E&I, or Automation please more »
testing plans and data template ready for testing. Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures. Design, plan and execute Physical testing in support of R&D activities and base business projects in accordance with applicable and procedures and guidelines. … with academia Understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation. Good working knowledge of Microsoft Office, specifically Word and Excel. Have an understanding of the role of Physical Testing within the product more »
We are looking for a Maintenance Technician to work 4 days a week (Monday to Thursday) on alternating early and late shifts. The main purpose of the role is to carry out equipment maintenance and calibration services as required by more »