Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits andCAPA 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 correctiveand 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 »
experience Responsibilities: Enhance operational procedures to meet business efficiency goals. Lead improvement initiatives with clear targets, plans, and KPIs. Decrease non-conformance through effective CAPA implementation, involving operational teams. Support Quality Management system development for driving improvements. Oversee internal audits and Supplier Quality Assurance. Handle customer complaints and represent quality more »
Cheshire, Chester, North West Hybrid / WFH Options
Real Staffing
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 andmore »
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 »
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 »
Bolton, Greater Manchester, North West, United Kingdom
Russell Taylor Group Ltd
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 »
inspections by customers, internal auditors and external regulatory bodies. Ensuring the QA function and site is continually inspection ready and supports development of site CAPAand responses Developing and improving the site processes for Document Control and Training Reviewing and approval of reports, procedures, policies, critical and major non-conformances 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 »
and release. Responsibilities: Supplier Management (SCARS, KPl’s, Supplier Assessments, Supplier Agreements, supplier requalification, supplier monitoring) External audits of suppliers Non-conformances (NCMR andCAPA) Customer Complaints Product inspection Review, inspection and authorisation of labels Review & approval of Device History Records (DHR) and other production documentation Execute Product Release Revision more »
Rugby, Warwickshire, West Midlands, United Kingdom
Jefferson Wells
Experience Levels: Relevant business/commercial or manufacturing/engineering degree preferred, or HNC, or equivalent NVQ level 4 qualification. Root-cause analysis, corrective, andpreventiveaction 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 »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »
Loughborough, Leicestershire, East Midlands, United Kingdom Hybrid / WFH Options
Almac Group (Uk) Ltd
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: CorrectiveandPreventiveAction (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). • Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance andmore »