1 to 25 of 46 CAPA Jobs in the UK

supplier audits; Support continuous improvement projects; Monitor customer and supplier rejects and highlight trends whilst implementing preventative and corrective actions to prevent reoccurrences; Complete CAPA, 8D or SCAR paperwork for customer returns Issue and update regulatory declarations (REACH, TOHS, TSCA etc); Complete supplier questionnaires for customers; Issue quarterly board updates more »

Analytical Team Leader (Raw Materials) Hours : 37.5 hours per week worked over a flexible work pattern Salary : Competitive and dependent on experience and suitability Ref No : HRJOB8642 Business Unit : Pharma Services Location : Loughborough, Leicestershire Open To : Internal and external candidates more »

their Improvement Culture, using your insight and analysis from performing audits as to were improvements can be implemented Play an instrumental part in their CAPA division within their Quality Team, this means that you will take the reigns on investigating non-conformances and collaborate on CAPA objectives. Working with the … client) Hands on knowledge of IS0 3485 i.e. you have worked in medical device manufacturing in a quality engineering role. Solid understanding of running CAPA driven activities, therefore you will be able to provide examples of where you have worked on CAPA driven initiatives within medical device manufacturing. Thank you more »

advantageous.Flexible approach who can learn and adapt quicklyKeywords:Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch, release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change, control, operations, senior, leader, supervisor, manager, coach, mentor more »

Good Manufacturing Practice (GMP) guidelines. Providing compliance support and spreading the quality culture throughout the company. Maintain processes (GMP documentation lifecycle, Change Control, Deviation, CAPA, self-inspections, Complaints, GMP document control and training) needed for successful site compliance to the PQS. Participating in reviews and suggesting improvements delving into areas more »

and working to support and track actions that are to be taken. •Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. •Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections. more »

As the Responsible Person, you’ll ideally have experience in the following; Quality, compliance, or regulatory experience within a GDP environment Change control experience CAPA experience Good GDP knowledge What should you do next? This Responsible Person role is one not to be missed; it encompasses the opportunity to work more »

MHRA requirements. Manage the investigation of laboratory related transfusion incidents & errors. This also involves the reporting to MHRA, SHOT & DATIX as well as setting CAPA and trending analysis. Assist with the management of non-compliances highlighted in audits and inspections. Prepare Quality reports for the various departmental meetings. Please refer more »

applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and more »

and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement and CAPA management and implementationWork closely with Global Process Owners to ensure local implementation of global pharmacovigilance proceduresFor assigned countries, primary GPV point of contact for local … teams to develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholdersStrong collaborator and problem solverQuality mindset inc CAPA managementFluent in EnglishComputer literateAdditional InformationPersonal AttributesRequired: Strong communication skills, including across geographies and functionsStrong analytical/problem-solving skills and attention to detailAbility to manage more »

CFR, MDD/MDR and UKCA regulations) Assist in the logging, investigating, and documenting of all non-conformities Corrective and Preventative Action Reports (CAPA), Non-Conformity Reports (NC) Assist in the logging, investigating, and documenting of all product complaints Recall handling Prepare trending analysis data whilst escalating any trends to … of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable Experience of Internal Audit, ideally as a lead auditor (desired) Experience of CAPA/Complaints and Root Cause Analysis. Experience in writing processes compliant with standards. Due to their location, you will need to have a driving licence more »

tool for improvement as well as compliance and challenges existing practice where appropriate. Supports and process NC and/or Corrective and Preventive Action (CAPA) to address operational issues within the PPA areas. Supports with project related document and technical review. Generation and monitoring of data streams and analysis to … functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Strong knowledge and experience of CAPA and NC for medical devices A practical working knowledge of implementation of change control, and of all aspects of the process and equipment more »

requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations and CAPA actions linked to process/formulation non-conformances. Required Experience Qualified to at least BSc or equivalent in Chemistry or a similar technical discipline Good more »

findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate Corrective and Preventive Actions (CAPA) and Engineering Request Notes (ERN). Participate in ISO 9001, ISO 14001, and ISO 45001 internal audits. Attend Materials Review Boards (MRB) and process MRB more »

a high-performing technical operations and MSAT teams. Take a active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. EXPERIENCE Supervising or mentoring junior staff. Detailed understanding of immunology and more »

and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and CAPA management · Understanding of change management processes · Well versed with MS Office (advance users in Excel & PowerPoint preferred) · Excellent communication skills (written and oral) in English more »

process, facility, SOP, CSV, and study audits. Review and maintain the BioA Central Events log, ensuring timely completion of proposed corrective and preventative actions (CAPA) by management. Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised more »

a similar role within the Medical Device/Pharmaceutical industry · (Desirable) Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of more »

Provide day-to-day support and be responsible to maintain the effectiveness of the Quality Management System, including, but not limited to, Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Monitoring and Assessment and Product Release activities Contribute to strategic improvement projects to improve business processes … made available for sale in accordance with agreed lead-times To participate in the effective management of Customer Complaints, Regulatory Reporting, Non-Conformances and CAPA To prepare and analyse data for the purpose of Management Review To ensure that all Change Control activities are effectively controlled, and outputs are correctly more »

Principle Design Engineer Cardiff CF14 £60-65,000 Commutable f rom Cardiff, Newport, Bridgend, Caerphilly, Barry, Llantrisant, Pontypridd Benefits:- Highly competitive salary Bonus Opportunity 25 Days + Bank Holidays Employee assistance programme Matched 5% pension Funded company social events Free more »

Healthcare. For successful applicants, Polar Speed will process basic disclosure criminal record checks. Key responsibilities: Actively support quality processes such as non-conformance and CAPA management, change controls and risk assessments, and ensure that quality system is continuously improved with the objective of assuring GDP compliance. Oversee the warehouse and … returns and exceptions are correctly processed in a timely manner. Participate in regulatory and client audits, lead internal audits/self-inspections and prepare CAPA plans addressing any observations identified. Investigation and reporting of incidents, including deviations, non-conformances, client feedback and customer complaints, including the logging, notification, investigation, reporting more »

system (Agile); including but not limited to Policies, Manuals, Standard Operating Procedures, Training Instructions and Batch Records. This includes document review and approval. Perform CAPA Coordinator activities; coordination Quality Incidents and Deviations within a Quality Management System (Agile. Proactively contributing to continuous improvement initiatives and other general housekeeping duties. Taking … Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document Management Systems (EDMS) Experience with CAPA systems - Agile preferred Proficient with MS Word, Excel and Power-Point Join our team and contribute to a dynamic environment where your skills will be more »

applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and more »

to become part of a dedicated team. Keywords: Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change control, operations, senior, leader, supervisor, manager, coach, mentor. more »

a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. Qualifications: Detailed understanding of immunology and cell therapy. Demonstrable expertise in more »