that fuel the economy - and directly advise the owners and management teams that lead them. We'll broaden your horizons The Quality and RiskManagement Team (QRM) provides leadership, guidance, and tools to help partners and staff manage quality and risk matters. The team is comprised of an Advisory and Compliance Team, a Chief Information Security … You'll be encouraged to identify and draw attention to opportunities for enhancing our delivery and providing additional services to organisations we work with. Role Purpose The Business Information Risk Analyst's (BIRA) role is responsible for supporting the Chief Information Security Office (CISO) service to BDO's business streams to effectively manage information security risk. This role will … play a key part in ensuring the effectiveness of BDO's information security riskmanagement framework, procedures, and information security controls. The BIRA role is a focal point for effective engagement between business streams and the CISO team. This role will be a trusted adviser to business stakeholders and provide broad knowledge of the firm's security strategies More ❯
global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for … direction and governance for QA-owned e-systems, site IT systems, manufacturing systems and site laboratory systems. • Develop and maintain quality assurance procedures, policies, and systems related to data management, and CSV. • Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices), Data Integrity and other relevant regulations. • Participate … lab systems validation and quality assurance. Required Skills: • Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality RiskManagement (QRM) and biopharmaceutical regulatory requirements. • Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation. • Proficiency with validation frameworks (e.g., GAMP 5), riskmanagement, and More ❯
be responsible for reviewing and approving batch documentation, providing quality oversight across manufacturing operations, and contributing to continuous improvement initiatives. The QA Officer will also participate in essential Quality Management Processes including unplanned events, complaints, CAPA, change control … product recalls, and system-based processes such as Blue Mountain and SAP. Essential Skills, Experience, or Qualifications: Experience working in a QA environment with sound knowledge of cGMP and QRM Experience reviewing batch documentation Experience with cleanroom environments Experience with Quality Events (QEVs) or similar A level or equivalent, including a science subject or evidence of science-based education/ More ❯