well established QA function. KEY RESPONSIBILITIES: Coordinating the implementation of the company's quality management system pertaining to GoodClinicalPractice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards. Serving as the main point of contact and providing support … Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers. Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations. Overseeing Change Controls, Deviations, and Corrective and … any findings. Delivering training to laboratory teams as needed. Experience Needed: Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories. Experience in providing quality support for Cell or Gene Therapy programs is highly more »
The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … goodclinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »
Director, QA (GCP) Full-time, Permanent London- Hybrid Model Summary: I am currently working with a pioneering biotech reshaping healthcare through genetic engineering and personalized medicine. In this crucial position, as the Director QA GCP, your responsibility will be to assist upper management in guaranteeing that Quality remains a central … focus in all corporate endeavors. More specifically, you will serve as a consultant to the Clinical Development teams, providing guidance on GCP activities related to quality. Primary Responsibilities: Defining, maintaining, and monitoring the GxP Quality Management System (QMS). Making sure the QMS meets all the necessary regulatory requirements … with a strong focus on GCP compliance. Supporting and guiding the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues. Handpicking and documenting responsibilities for external contracted organizations that support the GxP activities. Keeping a close eye on the performance of the GxP more »
their laboratories engaged in exploratory analysis of patient samples. You will be responsible for: Implementation of the company's quality management system relevant to GCP, including laboratory analysis of clinical samples, external vendor oversight, and training on quality procedures Acting liaison and support for Immunomonitoring and R&D labs … training to laboratory teams and eQMS users Plan and conduct of audits, including internal, vendors, clinical sites, and external laboratories Provide guidance on GCP/GCLP/GLP to clinical project teams You will bring the following: Previous experience in GCP QA role, as well as working in … Clinical laboratories Experience in Biologics, Steriles, CGT, or ATMP is highly desirable In depth knowledge of GCP and GCLP practices and regulations eQMS experience including implementation and administration more »
an extremely cutting edge area of the life sciences space. chance to sit alongside the businesses senior leadership team, having full autonomy of the clinical division within the QA department. a small team of quality professionals, supporting with development and training. You will be responsible for: the businesses quality … high standard and aligns with regulations. CQA oversight and support to Pre-Clinical and Clinical Operations. and host regulatory inspections within the GCP remit. You will bring the following: extensive number of years working at a senior manage level within GCP/GLP function. track record of establishing more »
met. • Oversees and performs complex ǪA activities involving evaluating and reviewing processes to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including. • Identifies and communicates significant quality … Requirements • Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to ǪP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met. • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic more »
Senior Project Clinical Data Manager We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong leadership team who are accelerating growth and have a great vision for the future. The offices are very modern and they have a fully … primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer’s expectations, taking responsibility for resourcing and planning of assigned projects. Provide hands on technical data … RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings Essential Degree or equivalent Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards SAS programming Detailed experience of end to end Clinical trial and Project Data Management processes, as well more »
Job Title: Head of/Director Quality Assurance (GCP) Location: Central London (4 days on site) Type: Full-time, Permanent A renowned organisation specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks a dedicated Head of/Director Quality Assurance. Embracing a culture of excellence and … the development of transformative therapies. Responsibilities: Oversee quality assurance initiatives throughout the organisation, fostering a culture of continuous improvement to ensure compliance with ICH-GCP Guidelines and other regulatory standards. Identify and communicate observations or deviations encountered in day-to-day operations, actively participating in their resolution to maintain quality … Incident Reports (IRs) through the electronic Quality Management System (eQMS), driving continual quality enhancement. Review and approve Quality Documents to ensure adherence to ICH-GCP standards and process improvements, leveraging the eQMS. Prepare for and host external Sponsor audits or Inspections, facilitating timely provision of documentation and addressing findings through more »
experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth. I am working with a Clinical stage biotech company that are pioneering the development of regenerative medicines. There is a pipeline of several ATMPs that are at the forefront of … clinical medicine for ocular diseases. They are looking for a QA Manager, you will be responsible for providing QA Support to manufacturing operations. … Are you a QA Manager that has experience Performing QA Duties to ensure manufacturing, testing and clinical trial activities that comply with GMP, GCP and other regulatory guidelines Document Control systems Change Controls CAPA - Corrective and Preventative actions Deviations & OOS reporting Compliant and recall handling Performing internal Audits Write more »
Job Title: Project Coordinator Department: Project Management Company: WEP Clinical Location: Hybrid - Chiswick Tower, London, England Do you dream of being part of a team that brings hope to those who need it most? Are you searching for a career that challenges you and allows you to grow as … a professional? At WEP Clinical, we are expanding, and the opportunities for personal and professional development are endless. Our team is committed to providing patients with early access to life-changing medicine every day. We encourage our team to bring their most creative and innovative ideas. Join us today … ensure projects are completed in accordance with client expectations. Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements. Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master more »
of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »
duties of the job Working autonomously, under the direction of the relevant research team leader, the post holder will collate data produced by the clinical teams and enter appropriately into paper or electronic case report forms (CRFs). In addition, the … post holder will liaise with trial sponsors to ensure timely transfer of data, and resolving any data queries, working within the guidelines of ICH GCP and local SOPs at all times. Other responsibilities will include assisting with the creation and maintenance of Investigator site files and databases of clinical … Values Education & professional Qualifications Essential oScience related degree or equivalent oKnowledge of drug development process and concept of clinical trials oKnowledge of ICH GCP Experience Essential oExperience of working under minimal supervision oExperience of working as part of a team oExperience of working to deadlines oComputer literacy to include more »
