quality associate - part time.

My client, a Life Science company, has a requirement for a Senior QA Officer to join the business at their Nottingham site. As Senior QA officer, you will:Ensure new assays, services and processes are implemented in accordance with the relevant quality standards.Ensure requirements of ISO 9001, ISO 15189, HTA and Good Clinical Practice (GCP).Perform gap analyses against the relevant standardLook for areas of potential problems and improvementsConduct start-up audits for new servicesNon-conformance/CAPA ComplaintsChange ControlTo be considered for the role of Senior QA Officer, you will:At least 3 years in a similar positionEducated to degree level in a science-based fieldISO 15189 or ISO 17025 experienceHave experience performing internal auditsQ-Pulse or similar Electronic Quality Management desirable Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

My client, a leading CRO has a requirement for a flexible Clinical Research Associate to oversee IVD clinical trials on a fixed term contract.Clinical Research Associate Responsibilities:Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.Training site staff on protocol requirements, proper source documentation, and case report form completion.Tracking and managing IVDs and trial materials.Conducting regular monitoring visits and close out visits and writing visit reports.Implementing action plans for sites not meeting expectations.Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.To be considered for the role of Clinical Research Associate, you will:Hold a Degree in Biological or Medical Science or a related field.Experience with IVD and /or Medical Device studies2+ years of experience as a Clinical Research Associate.Knowledge of the Medical device industry, terminology, and practices.Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.To be successful in this role, you should be able to recognise logistical problems and initiate appropriate solutions. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

My Client, a leading Pharma Biotech has a requirement for a Associate Quality Document Manager on a six month contract.Perform QC review to ensure documents authored by the Aggregate Safety Reports.Perform QC Review of documents produced by Safety team.Verify data in assigned documents against source documentation, including checking text against database outputs.Perform editorial and technical review for grammatical and stylistic consistency in line with the business guide document templates.This includes reviewing format, internal linking, and external cross-referencing.Document QC findings so that appropriate actions can be taken by authors.Where needed, meet with the author to discuss findings and strategies the next steps, including support with the development of preferred text.Document QC metrics for quality tracking.As Associate Quality Document Manager, you will:Educated to Degree level in science related field Comfortable with medical concepts and terminology; familiar with the American Medical Association ManualFamiliar with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.Ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format.Proficient and comfortable using Microsoft Office (in particular, Word, Excel, and PowerPoint) and SharePoint platforms.2-3 years writing and editorial experience in pharma This role is Inside IR35 on a 6 month Contract. Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.