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 »
Cardiff, 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 »
staff on quality protocols. Responsibilities: Develop and improve quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards (e.g. BRC, GMP) Conduct regular audits and inspections of laboratory and manufacturing processes, equipment, and documentation to identify areas for improvement. Gain expert knowledge of the business management more »
degree level or above in life sciences, chemistry or a related file with experience of working in a regulated laboratory environment (e.g. GLP or GMP) • Experience in using and troubleshooting ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA. • The ability to document more »
safety and legality can be assured and that all the necessary information is accurately recorded and retained The Position: Carry out Daily/weekly GMP audits as required. To complete a detailed shift report at the end of every shift. To audit daily process documents including monitoring weights on line more »
development. Work with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery. Ensure current GoodManufacturingPractice (cGMP) compliance. Maintain a safe working environment compliant with all relevant Environment, Health and Safety (EHS) requirements. Maintain and expand the cGMP QC services … and product specifications, Certificates of testing, Stability Study Protocols, Method Qualification Protocols and Reports. Manage the ongoing environmental monitoring and water testing of the GMP facility and operation. Manage the investigation of out-of-trend (OOT), out-of-specification (OOS) and any deviation events. Ensure that all regulatory expectations are … met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived. Provide timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients. Has budgetary responsibility for the QC department including management of spend and equipment capital expenditure ensuring development more »