Proclinical Group

Ready to lead quality analysis that helps bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference! Proclinical is recruiting for a dedicated Quality Analyst to support the digital transformation journey of a manufacturing site, focusing on implementing and maintaining IT systems that align with GMP regulations. This role will primarily involve working with Quality Systems such as LIMS, CDS, and other QC equipment applications, while also supporting broader manufacturing IT needs. You will collaborate with cross functional teams, including business stakeholders, IT colleagues, and external vendors, to deliver effective solutions and ensure ongoing system compliance and optimization. Please note that to be considered for this role you must have the right to work in this location or hold an EU passport. Responsibilities Implement and maintain IT systems and processes in line with GMP regulations, focusing on Quality Systems (e.g., LIMS, CDS, QC equipment applications). Provide day to day IT support, including issue resolution, system changes, and service optimization. Manage IT requests via the ticketing system and ensure timely responses. Facilitate deviation and CAPA management, ensuring regulatory compliance and continuous improvement. Author and update validation documentation, IT data processes, and other compliance related materials. Support audits and inspections related to IT quality and regulatory compliance. Collect business requirements and translate them into solution specifications. Participate in application design discussions and ensure adherence to established standards. Lead or support validation activities for IT systems and software applications. Conduct testing and implementation of new applications, ensuring cybersecurity compliance. Identify opportunities for process improvements and implement strategic changes to enhance operational efficiency. Stay updated on industry trends, regulatory changes, and best practices related to Quality Systems and Smart Labs. Contribute to smart factory initiatives and collaborate with other teams as needed. Key Skills and Requirements Background in computer science, information systems, or equivalent experience in a regulated environment. Experience supporting pharmaceutical quality and manufacturing systems. Knowledge of system lifecycle management and computer systems validation (CSV), preferably GAMP5. Hands on experience with LIMS, CDS, and Quality Systems. Familiarity with ITILv4 and project management principles. Proficiency in SQL, data management, and analytics is advantageous. Strong problem solving skills and attention to detail. Excellent communication skills, with the ability to explain technical concepts to non technical colleagues. Collaborative mindset and willingness to work closely with Quality and other business teams. Self starter with the ability to manage multiple projects simultaneously.

Proclinical Group is seeking a dedicated Quality Analyst to support the digital transformation journey of a manufacturing site, focusing on implementing and maintaining IT systems that align with GMP regulations. This role will primarily involve working with Quality Systems such as LIMS, CDS, and other QC equipment applications, while also supporting broader manufacturing IT needs. Please note that to be considered for this role you must have the right to work in this location or hold an EU

Ready to engineer precision in the world of medical devices? Join a cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow's breakthroughs. Proclinical is seeking a Senior Software Engineer to join a dynamic and interdisciplinary team. In this role, you will contribute to the development and enhancement of software solutions, with a focus on Python development and cloud-connected applications. This hybrid position requires two days per week in the office in Watford. Responsibilities Develop and maintain software using Python, including writing tests with pytest and implementing software design patterns. Debug, read, and make targeted changes to C/C++ codebases as needed. Work with WebSockets, Web APIs, and cloud-connected applications. Utilize Linux utilities such as v4l2, ntp, systemd, journalctl, and iptables for development and troubleshooting. Apply networking fundamentals, including TCP/IP, DNS, NAT, and related debugging workflows. Collaborate within an interdisciplinary agile team across cloud, mobile, web, and embedded engineering. Clearly discuss technical trade-offs and work collaboratively to reach practical engineering solutions. Key Skills and Requirements Proficiency in Python development, including testing frameworks like pytest and mocking techniques. Ability to navigate and modify C/C++ codebases. Experience with WebSockets, Web APIs, and cloud-connected systems. Familiarity with Linux operating systems and associated utilities. Strong understanding of networking principles and debugging workflows. Effective communication skills and experience working in agile, interdisciplinary teams. Knowledge of video engineering technologies such as FFmpeg, GStreamer, live streaming, or WebRTC. Understanding of video streaming protocols and metrics, including WebRTC, RTP/RTSP, HLS/DASH, latency, jitter, packet loss, bitrate, frame drops, and buffering. Experience with resource-constrained or embedded platforms. Familiarity with cloud services, preferably AWS.

Proclinical is seeking a Senior Software Engineer to join a dynamic, interdisciplinary team in a hybrid role with two days per week in Watford. You will develop Python software, work with C/C++ code, and contribute to cloud-connected systems. The role emphasizes testing, patterns, and effective collaboration across cloud, mobile, web, and embedded domains. The ideal candidate will have strong Python skills, proficiency with pytest, and experience with FFmpeg, GStreamer, or WebRTC in

Are you looking to drive groundbreaking quality assurance and make a real impact? Join our client and lead the way in advancing clinical quality assurance! Proclinical is looking for a Quality Assurance Manager to join a dynamic organization on a permanent basis in the UK. This role offers flexible home and/or office working, industry leading training, and a competitive total reward package. The primary purpose of this role is to support the Director of Quality & Compliance in delivering Quality Assurance activities and overseeing, maintaining, and improving the Quality Management System (QMS). You will play a key role in ensuring compliance with applicable regulations and internal procedures, supporting audits and inspections, contributing to continuous improvement initiatives, and promoting a culture of quality across the business. This role provides an opportunity to take ownership of key QA processes and collaborate closely with stakeholders across the organization to drive high standards of quality and compliance. Responsibilities Quality Assurance Manage the Quality Management System (QMS). Contribute to the generation and management of the internal audit schedule. Independently conduct and report audits in accordance with the internal audit schedule. Conduct vendor audits as instructed. Lead, manage, and coordinate client audits and regulatory inspections. Respond to and follow up on audit reports and vendor questionnaires. Review and provide QA approval of SOPs and other controlled documents. Effectively monitor compliance with processes. Provide input for and maintain oversight of CAPAs and quality issues. Generate quality metrics reports to update the management team on quality-related issues and initiatives. Ensure company-wide compliance with EU and UK clinical trial legislation, ICH GCP, and other applicable regulations. Perform QA reviews of Computerized Systems Validation (CSV) projects. Conduct risk assessments where required. Quality Improvement Promote good practices by challenging existing standards and suggesting areas for improvement. Inspire and drive the organization to achieve and maintain quality values. Review lessons learned from meetings, customer concerns, issues, and CAPAs for quality-related items, and coordinate any resulting training or process updates. Training and Development Develop, coordinate, and deliver training materials related to quality, including GCP. Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training. Data Protection Assist the Data Protection Officer (DPO) with data protection activities. Ensure adherence to applicable legislation, including GDPR. Information Security Assist in hosting ISO27001 accreditation and subsequent surveillance audits. Review SOPs for information security compliance and draft new SOPs/policies as required. Conduct internal and vendor information security audits. Support information security assessments of the organization. Conduct information security assessments of potential vendors. Assist with managing potential and actual data breaches in conjunction with relevant teams. Key Skills and Requirements Training and proven years of working experience in Good Clinical Practice (GCP). Professional working years of relevant QA experience, preferably within the life sciences sector. Other Information/Additional Requirements: Expert knowledge of UK, EU, and US clinical trial legislation. Strong ability to communicate effectively and influence across and within the organization. Excellent written and verbal communication skills. Exceptional interpersonal and negotiation skills.