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 »
a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, correctiveactionpreventiveaction (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. Qualifications: Detailed understanding of immunology and cell therapy. Demonstrable expertise in more »
experience. 2 years’ experience working in a Quality Assurance role. Experience of with assessing telephone calls in a call center is preferred. Deviations andCAPA handling experience. Quality or Six Sigma Certifications are an advantage. Work in a professional manner with clients, team members and management. Analytical skills to gather more »
control system o quality risk management o training system o qualification & validation o change controls o leading Internal audits o correctiveand 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 »
a similar role within the Medical Device/Pharmaceutical industry · (Desirable) Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of 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 »
Alderley Edge, Cheshire, North West, United Kingdom
Russell Taylor Group Ltd
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 - Correctiveand Preventative actions Deviations & OOS reporting Compliant and recall handling Performing internal Audits Write and review of documents - SOPs, Qualification/validation reports 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 »
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 »
KPIs) as required. Analyze company data to identify potential quality issues and support initiatives for product and process improvement. Initiate CorrectiveandPreventive 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 correctiveandpreventiveactionand project/activity lessons learnt through recognised tools/techniques including Cost of Quality setting, implementing, and monitoring Improvement KPIs across the 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 »
control audits and recording through approved channels as required. Report all incidents and adverse events to senior staff and enter the information in the CAPA module of Q-pulse in a timely manner as directed by senior staff. Demonstrate on going competency against training plans. Report all incidents and adverse 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 »
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 »
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 »
in reporting and assessing the suitability of our data to support verification and validation of the product's requirements. Operating under change management andCAPA 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 »