1 to 25 of 30 CAPA Jobs in England

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 »

requirements and processes in the life sciences industry Demonstrated knowledge or ability to comprehend document management, training management, audit management, risk management, change management, CAPA management, and Non-Conformance processes. BS/BA degree in Science, Engineering or Business Administration OR an equivalent combination of education and work experience Excellent 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 »

Key Words: QA | Quality Assurance | QMS | Quality Management Systems | Clinical | GMP | GxP | Biotechnology | QDM | Quality Document Management Systems | Electronic Document Management Systems | Drug Discovery | CAPA | Deviations 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 »

control system o quality risk management o training system o qualification & validation o change controls o leading Internal audits o corrective and preventative actions (CAPA) o vendor qualification o deviation & OOS reporting o batch record review prior to ǪP release o manage Product Specification Files for ATIMP’s o complaint 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 »

elements of the PQS relating to manufacture and testing of cellular therapies including; Document control system, Training system, Change controls Corrective and preventative actions (CAPA) Deviation & OOS reporting Quality risk management Participating in internal audits Vendor qualification Batch record review prior to QP release Maintaining product specification files for ATIMP 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 »

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 »

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 »

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 »

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 »

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 »

policy eliminating failures whilst maximising efficiency of the manufacturing process and ensuring adherence to all aspects of the company's accreditation Oversee the Corrective and Preventive action process, co-ordinating CAR root causes and corrective actions for both in-house and customer returns (RMA) and complaints, with follow up checks 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 »

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 »

on site) Essential experience of the Lead Auditor: Experienced Auditor. Extensive knowledge and ability to apply standards of ISO9001, ISO14001 and/or ISO45001. CAPA (Corrective Action Preventive Action), root cause investigation and verification. Proven experience within an audit and quality assurance background. Excellent verbal and written communication skills. Knowledge 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 »

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 »

of processes during the initial design phase. Tasks and responsibilities will include: Facilitate root cause analysis and practical problem-solving. Establish and implement corrective and preventive action plans for improving engineering performance and deliverables. Identify and address risks/issues related to engineering quality through standardized mitigation plans. Skills: Relevant more »