1 to 25 of 42 CAPA Jobs

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 »

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 »

experience. 2 years’ experience working in a Quality Assurance role. Experience of with assessing telephone calls in a call center is preferred. Deviations and CAPA 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 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 »

of objects and manage MES master data such as Products, Locations, Equipment, and Materials.* Assist in fulfilling quality record requirements, including process change controls, CAPA, and deviations.* Draft and execute test scripts for recipe validation (IQ, OQ, PQ).* Establish and enhance interfaces with other systems such as ERP, LIMS 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 »

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 »

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 »

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 »

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 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 »

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 »

projects. Assisting in the completion of the Validation Master Plan. Auditing (internal and external). Equipment maintenance and calibration. Root cause analysis investigations. NCRs CAPA Compliant investigation. Requirements: Educated to degree level in a relevant scientific or engineering discipline. Significant experience working in a similar role within the medical device 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 »