1 to 25 of 36 Permanent CAPA Jobs in the UK

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 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 »

audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. more »

the audit schedule, including coordinating and performing audits for studies, systems and vendors as Lead Auditor. Timely distribution of audit reports, evaluation of Corrective and Preventive Action and maintaining the audit schedule in the eQMS, adapting priorities and documenting changes or updates as needed. To ensure review of Computer System more »

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 and review of documents - SOPs, Qualification/validation reports and more »

audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors. Execute validation protocols and drive to completion any CAPA associated with non-conformances raised. Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed. 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, management and post audit follow up of customer audits and regulatory more »

development and troubleshooting including reviewing protocols, study plans, SOPs or reports as required. 4. You will document and complete any quality documentation (quality issue, CAPA, deviation, change control) as appropriate and within required time frames. ROLE REQUIREMENTS: To be successful in your application to this exciting opportunity as the Study more »

apply QC procedures to ensure their accuracy • Produce and review/approve relevant documentation such as protocols, procedures, validation/study reports, SOP’s, CAPA’s, file notes. • Provide technical advice to business development and participate in laboratory-related discussions with auditors, Sponsors and internal employees. • Perform routine maintenance/ more »

experience in Laboratory, Production or Pharmacy who are looking to move into a QA role full time are also encouraged to apply. Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling etc. Strong IT skills (Microsoft applications) Good interpersonal skills and strong written/verbal communication skills more »

KPIs) as required. Analyze company data to identify potential quality issues and support initiatives for product and process improvement. Initiate Corrective and Preventive Actions (CAPA) and Engineering Request Notes (ERN) based on thorough analysis. Conduct internal audits of ISO9001, ISO14001, and ISO45001 Management Systems, ensuring compliance and following up on more »

Provide regular status update reports on Project quality goals, leading/lagging quality indicators and non-conformance management. Drive quality improvement through robust corrective and preventive action and project/activity lessons learnt through recognised tools/techniques including Cost of Quality setting, implementing, and monitoring Improvement KPIs across the 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 »

raw material specifications as required. Furthermore, you'll generate Quality Attribute Sheets compliant with customer and legal specifications, report any non-conformities through the CAPA system, and take appropriate action while documenting relevant information. Lastly, you'll review manufacturing processes and collaborate with production/technical teams to enhance systems more »

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 »

Experience Levels: Relevant business/commercial or manufacturing/engineering degree preferred, or HNC, or equivalent NVQ level 4 qualification. Root-cause analysis, corrective, and preventive action skills Must be able to work in a team and across teams. Must be able to explain/mentor and coach across all more »

one of the following regulated industries: ISO 9001, AS 9100, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in quality systems auditing. Experience in inspection, including first article inspection. Experience in planning and conducting supplier audits. The Package: Up to more »

to address constraints. Lead the execution of common IT processes across Data Platforms solutions and services. (ie. Access Roster Reviews, Periodic Reviews and other CAPA activities.) Represent the team in vendor governance meetings and ensure compliance with change management and ITSM processes. Minimum Qualification (education, experience and/or training more »

in reporting and assessing the suitability of our data to support verification and validation of the product's requirements. Operating under change management and CAPA systems when in appropriate stages of development. Work in accordance with 21 CFR part 820, ISO 13485, ISO 14971, IVDR, and other applicable regulations. Knowledge 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 »

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 »

assess external customer complaints in the global Elanco complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods. To maintain a batch record review qualification status of contract manufacturers. To monitor and to drive EEM-EMEA CAPA system. more »