Sinclair are currently recruiting for a Risk Management Engineer in the UK with once a month travel to their Chester or London office dependent on where the candidate is located. This is a 6 months fixed term contract. The Risk Management Engineer will report into the Risk Manager to contribute directly to meeting regulatory submission and launch timelines of medical devices and aesthetic products. The Risk Management Engineer is responsible for maintaining risk management activities for legacy devices and supporting new product development activities. The ideal candidate will have a minimum of 5 years … experience in the regulated medical device industry and knowledge of usability engineering for medical devices. As well as experience in performing risk management for medical devices. Location: Once a month at either of our offices 30-32 Whitfield Street, London, W1T 2RQ/Eden House, Lakeside, Chester Business Park more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product lifecycle. Develop, approve, and monitor the risk based GxP audit programme and budget for Dechra DPMS. Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully … Lead GMP/GDP audits for Dechra DPMS based on specific expertise, criticality, and complexity. Periodically assess the liability, regulatory and/or quality risk to Dechra's products, reputation, and operating licenses through the programme of audits and risk assessments, escalating and reporting the results accordingly. Maintain … oversight of the Dechra DPMS audit master schedule and coordinate the audit planning with the wider audit team and Group Risk Management to ensure that products currently marketed, supply chain optimisation exercises, service providers as well as transportation and distribution networks are all being adequately monitored. Recruit, lead, train more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
wider Dechra Quality community to develop, approve, monitor and maintain critical quality standards to proactively minimise product quality risks including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality. Supports the wider Dechra Quality team members regarding the requirements for product and process … regulations related to GXP. Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms. Biotechnology experience is desired. Proficient in riskassessment and mitigation tools and processes Skills : Excellent problem solving and decision-making skills. Strong interpersonal skills, collaborative and team building skills. Broad more »
Modules as identified in the design – PLC code modules, SCADA scripts, Mimics, comms drivers, etc.) Develop site work documentation with team input as necessary (Riskassessment, method statement, site test documentation) Develop O & M documentation Undertake full integrated system testing, CFAT, SAT and installation Undertake observations, variation and more »
qualification to degree level or alternative route Detailed knowledge of the UK framework for Electrical systems & SHE standards - BS7671 & 2391 are essential Experience of RiskAssessment, COSHH and permit to work processes essential Knowledge of high voltage switchgear and distribution networks Extensive experience in leading EC&I capital more »
Skills and Qualifications You will be required to have: Knowledge of the legislation, guidance and practice in relation to contaminated land, including graphical databases, riskassessment and remediation. The ability to understand and analyse technical matters and a willingness to continue to develop IT skill... more »
Skills and Qualifications You will be required to have: Knowledge of the legislation, guidance and practice in relation to contaminated land, including graphical databases, riskassessment and remediation. The ability to understand and analyse technical matters and a willingness to continue to develop IT skills. Benefits All of more »