26 to 50 of 52 Permanent CAPA Jobs

that an escape occurs, the engineer also makes sure that the proper root cause investigation is conducted and that planned, tested, and implemented corrective and preventive action is taken. Experience/Skills: Extensive knowledge and experience with statutory regulations for global market products, particularly electrical/electronic systems. Ability to more »

documents related to laboratory operations/testing through editing of documents and/or reviewing revisions •Support quality system improvements through completion of Corrective and Preventive Action forms, documenting Non-Conformances and assisting with internal audit findings as assigned by Environmental Lab Supervisor, Monograph Supervisor, Lab Supervisor, or Food Chemistry more »

documents related to laboratory operations/testing through editing of documents and/or reviewing revisions •Support quality system improvements through completion of Corrective and Preventive Action forms, documenting Non-Conformances and assisting with internal audit findings as assigned by Environmental Lab Supervisor, Monograph Supervisor, Lab Supervisor, or Food Chemistry 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 »

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 »

assessments. • Participates in projects, initiatives, and process improvements. • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. • May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections. Skills: analytical chemistry 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 »

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 »

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 »

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 »

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 »

is an opportunity that offers competitive benefits, great pay, and room for growth. Description: Ensure full control of QA core documents (i.e., MMR, BPRs, CAPA), SOP's, QA investigations & reports, CAPA's, and implement activities with the QC and production teams Provide data analysis in support of customer requests. Collect more »

GMP). • 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 »

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 »

and manage the existing QMS and work closely on the implementation and transition to an eQMS. Alongside this you will be heavily involved in CAPA & NCR processes, SOP creation, auditing and RA support. We are looking for an experienced Quality Assurance professional with a proven background in In Vitro Diagnostics … or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing. Key Responsibilities: Develop and Maintain ISO 13485 QMS Support the implementation and transition to an eQMS Creation and implementation of SOPs CAPA Process Auditing Support RA … IVD or Medical Device Industries Proven experience in the maintenance and/or implementation of an ISO 13485 QMS Proven experience and knowledge of CAPA Process and Auditing Auditing certification is highly advantageous If you have the necessary skills and experience to be successful in this role, please get in more »

Teams & email communications regarding product quality Telephone, MS Teams & email communications regarding ongoing product/process improvement activities Telephone, MS Teams & email communications regarding CAPA activities Other Telephone, MS Teams & email communications as deemed required by the Quality Manager at the Dundee site Draft/update/improve supplier quality … well as NCMR/CARs assigned by or to other Smiths Interconnect sites. SUPPLIER Quality & Development – Partner with supply chain in adequate completion of CAPA requests due to nonconforming or discrepant material. Collaborate with regularity ensuring supply chain partner are engaged in continual improvement activities. MRB ACTIVITIES - Coordination of MRB more »

and supporting continuous improvement in the manufacturing and warehouse environments. As well as writing/modifying SOPs, you will be involved in deviation and CAPA process oversight and will also review site training requirements. This is a highly varied position and needs someone that can be versatile and manage competing … QC, control, analytical, chromatography, HPLC, laboratory, documentation, analyst, officer, specialist, executive, administrator, good, manufacturing, practice, GMP, GLP, audit, SOP, training, complaints, batch, review, release, CAPA, deviation, change, control 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 »

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 implementation Work closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures For assigned countries, primary GPV point of contact … develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders Strong collaborator and problem solver Quality mindset inc CAPA management Fluent in English Computer literate Additional Information Personal Attributes Required: Strong communication skills, including across geographies and functions Strong analytical/problem-solving skills more »

Change Control documentation for Quality Assurance Support the maintenance of Quality System documentation Analyse and communicate proposed, new or changing requirements Review and approve CAPA documentation Provide support to routine manufacturing activities, projects, development and training Experience required: Experience working in Quality Assurance Experience operating in ISO9001 environment Excellent working … knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory Specialist, Quality Assurance Manager, QA Manager, ISO9001 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 »

processes to ensure the product is compliant with regulatory requirements. Responsible for responding to customer quality requests, completion of customer quality questionnaires. Review any CAPA and non-conformances raised in the IMS and working with owners to ensure adequate root cause analysis has been conducted and any corrections or corrective … Quality Systems function within an ISO 9001 Management System, or similar Experienced internal auditor for ISO 9001 or similar Experience of investigating/reviewing CAPA and an understanding of root cause analysis tools Experienced in QA/QMS activities such as documentation control and change control processes. Experience of responding more »

routing Be the voice of customers to Oracle’s various cloud engineering teams Leads deep dives into events during calls and in support of CAPA Works independently with minimum directions Minimum Qualifications: 8+ years of experience in an IT, platform environment working with large Enterprises Significant experience involving Compute, Networking … routing Be the voice of customers to Oracle’s various cloud engineering teams Leads deep dives into events during calls and in support of CAPA Works independently with minimum directions Minimum Qualifications: 8+ years of experience in an IT, platform environment working with large Enterprises Significant experience involving Compute, Networking 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 »

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 »