25 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 »

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 »

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 »

Support continuous improvement initiatives and promotes a quality mindset at all levels. Ensure compliant delivery through provision of risk-based advice and training Review CAPA Process to ensure effectiveness Support the development of a risk based audit programme Maintain network of external audit providers to support CMC, pre-clinical and 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

defined and applied within the business. • Coordination and leadership of reported quality/technical issues from business teams and customers, ensuring that appropriate corrective and preventive action is taken by the accountable function through use of multifunctional team activities and that the originator of the issue is informed. • To perform … To conduct investigations to assess the probable root cause of any deficiency noted during process confirmation activities, informing the accountable function, and ensuring corrective and preventive action is taken. • Compile and Present Quality overview to the leadership team within the business area Required Skillset: • Ability to interpret drawings. • Ability to more »

regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post market activities, internal and external audits and CAPA System. This is a home-based role (#LI-REMOTE) with occasional travel to our site in Llanberis. Your Role: You will provide support for post … market activities and representation on various product related meetings. You will be responsible for the effectiveness of CAPA, internal/external audits, input to Management Review at site level. You will support corporate QM function with site vigilance activities. You will support the site with internal and external investigations/ more »