1 to 25 of 30 CAPA Jobs in the UK excluding London

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 »

candidate will carry out evaluations of data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to 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 »

analysers. Good analytical approach to investigating operations & product quality issues. Experience of DNA extraction and quantitative analysis by spectrophotometry. Experience of OOS investigations and CAPA resolution. Strong pipetting skills. Methodical and organised approach to work. Computer literate with competence in MS Office and Genemapper. Closing Date: Sunday 28th, April more »

of objects and manage MES master data such as Products, Locations, Equipment, and Materials.* Assist in fulfilling quality record requirements, including process change controls, CAPA, and deviations.* Draft and execute test scripts for recipe validation (IQ, OQ, PQ).* Establish and enhance interfaces with other systems such as ERP, LIMS more »

that Data Management (DM) procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process. Key responsibilities include, but not limited to: Project level coordination of and day to day oversight of DM tasks including: Review all DM documents 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 Person: Will have a Degree in a relevant- Scientific discipline Will have good knowledge of GMP & experience in steriles is essential! Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous Strong IT skills (Microsoft applications) Good interpersonal skills and strong written/ more »

will be an advantage). Have good knowledge and experience of quality improvement/problem solving techniques such as: 5S, CoPQ measures, 8D/CAPA, Kaizen/PDCA, Six Sigma & DMAIC methodology, Statistical Process Control, visual aids management. Be certified as Lean Six Sigma Green Belt (will be an advantage 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 »

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 »

projects. Assisting in the completion of the Validation Master Plan. Auditing (internal and external). Equipment maintenance and calibration. Root cause analysis investigations. NCRs CAPA Compliant investigation. Requirements: Educated to degree level in a relevant scientific or engineering discipline. Significant experience working in a similar role within the medical device more »

corrective actions. 4. Establish and maintain quality policies, procedures, and documentation to support compliance with regulatory requirements. Management of QMS Processes such as NC, CAPA and Change. 5. Collaborate with cross-functional teams to integrate quality considerations into product development processes. 6. Provide training and guidance to employees on quality 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 »

of the Engineering Wing quality targets (Primary activity of role) Facilitate and support root cause analysis & practical problem solving activities Establish and drive corrective and preventive action plans in order to support the improvement of engineering performance and its associated deliverables Identify risks/issues relating to the quality of more »

PQCP, Risk Priority Number scoring, Verification & Validation definition) You lead Problems solving (Issue to Prevention) with effective Root Cause Analysis and ensure that corrective and preventive action prioritization in the backlogs. You lead the application of Directives related to E2E Quality Product (ex. DirQ32) In coordination with Chapter Leader, you 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 »

processes 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, required 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 »

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 »

Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations more »