1 to 25 of 44 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 »

a high-performing technical operations and MSAT teams. Take a active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance. EXPERIENCE Supervising or mentoring junior staff. Detailed understanding of immunology and more »

Good Manufacturing Practice (GMP) guidelines. Providing compliance support and spreading the quality culture throughout the company. Maintain processes (GMP documentation lifecycle, Change Control, Deviation, CAPA, self-inspections, Complaints, GMP document control and training) needed for successful site compliance to the PQS. Participating in reviews and suggesting improvements delving into areas 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 »

a high-performing technical operations and MSAT teams. Take an active role in the evaluation of deviations, root-cause-analysis, corrective action preventive action (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 »

to Medical Information or Pharmacovigilance services would be highly preferable Experience of with assessing telephone calls in a call center is preferred. Deviation and CAPA handling experience. Quality or Six Sigma Certifications are an advantage. Additional Information We celebrate our differences and strive to create a workplace where each person 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 »

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 audit schedule, including coordinating and performing audits for studies, systems and vendors as Lead Auditor. Timely distribution of audit reports, evaluation of Corrective and Preventive Action and maintaining the audit schedule in the eQMS, adapting priorities and documenting changes or updates as needed. To ensure review of Computer System more »

findings, and support supplier audits. Update Quality reports and KPIs. Analyze data for quality issues and support improvement initiatives. Initiate Corrective and Preventive Actions (CAPA) and Engineering Request Notes (ERN). Participate in ISO 9001, ISO 14001, and ISO 45001 internal audits. Attend Materials Review Boards (MRB) and process MRB 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 »

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 »

requirements. Work Closely with Mixing and Production in the development of IPC's for new products. Support all site functions with technical investigations and CAPA actions linked to process/formulation non-conformances. Required Experience Qualified to at least BSc or equivalent in Chemistry or a similar technical discipline Good 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 »

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 »

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 »

MHRA requirements. Manage the investigation of laboratory related transfusion incidents & errors. This also involves the reporting to MHRA, SHOT & DATIX as well as setting CAPA and trending analysis. Assist with the management of non-compliances highlighted in audits and inspections. Prepare Quality reports for the various departmental meetings. Please refer more »

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 »

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 »