responsibility Experience with data privacy regulations preferred Experience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of GoodLaboratoryPractice (GLP) and Good Clinical Practice (GCP) strongly preferred. RESPONSIBILITIES: Leadership. Strategic partnership with Global Quality Assurance team and Global Leadership Team Regional oversight of Quality Assurance … of a working knowledge of industry and regulatory standards and requirements Provision of guidance and leadership on Good Clinical Practice (GCP), GoodLaboratoryPractice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards Responsive escalation point for Clinical Trials quality issues and concerns Process Improvement. Development and execution of more »
pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and GoodLaboratoryPractice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's Audit program. Interfacing with business and functional … management. Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations. Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections. Participate in the … internal, 3rd party, and vendor audits. Process Improvement Responsibilities: Lead the development, improvement, implementation, and maintenance of new/modified quality systems to ensure GLP and GCP compliance. Recommend systems for audit, write audit plans, and coordinate scheduling and closure of internal audits. Training and Mentoring: Provide training and mentoring more »
health and safety procedures and guidelines. Education and experience: - Degree education in Chemistry, Chemical Engineering or other related Engineering discipline. - Knowledge of GLP (GoodLaboratoryPractice) quality requirements skills gained in similar work (or dissimilar but relevantly skilled work). - Awareness of REACH, CLP, ISO 21469, NSF, AS9100. - Awareness of more »