developing injectable dosage forms for preclinical & clinical use, this will include formulation development and product characterisation Appreciation of the regulatory environment, ideally GMP/GLP You will be able to coordinate multiple projects simultaneously You will be an effective team player and have strong interpersonal skills to enable you to more »
molecule bioanalytical studies. 3. A working knowledge and practical experience using LC-MS/MS. Key Words: Small Molecule | Study Manager | Team Lead | Bioanalysis | GLP | GCP | Method Development | Validation | Sample Analysis | Regulatory Compliance | LC-MS/MS Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified more »
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 »
Safety and Environmental requirements are met including (but not limited to) workplace organisation, work instructions, risk assessments, COSHH assessments, housekeeping standards in accordance with GLP and GMP n Demonstrable evidence of understanding the importance creating a safe environment n Working in a safe manner n Follow appropriate and relevant practices … achieve high standards Data and computer literate, fluent user of typical office software application packages, especially Word and Excel Working knowledge of GMP/GLP Delivers on commitments as per timelines and quality standards Shows a positive attitude in difficult situations 2 years working in an analytical laboratory environment Experience more »