resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business more »
Hatfield, England, United Kingdom Hybrid / WFH Options
Planet Pharma
undertaking work packages, ensuring safe systems of work are adopted throughout implementation phases. • Support for commissioning, qualification and validation activities. • Review and approval of GxP documentation, including technical specifications, user requirements, design/code reviews, qualification protocols and site acceptance testing. • Lead quality and engineering change controls to maintain the more »
design, build, and operational support OR 3+ years in a similar role with Manufacturing OT equipment, in Healthcare/Pharma. 3+ years working with GxP and GMP environments. If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lauren.mckinley@skillsalliance.com. more »
coordination with seasoned Principal Investigators, clinical research physicians, specialist nurses, technicians, and operations managers. Key Duties: • Ensuring Compliance and Quality Oversight: Supervising adherence to GxP (especially GCP) standards and providing quality oversight to personnel operating in GxP environments at the phase I Clinical Unit Cambridge (CUC) facility. • Managing Inspections and … Audits: Taking responsibility for GxP regulatory inspections and participating in audits. Direct engagement with regulatory agencies during on-site inspections and with Clinical Quality Assurance (CQA) auditors during on-site audits. • Upholding Regulatory Compliance: Guaranteeing compliance with all regulatory mandates. Overseeing the MHRA Phase 1 Accreditation Programme at CUC. • Handling … Issues: Providing oversight and guidance for complex or severe GxP issues, leveraging expertise in interpreting and applying regulations to unique compliance scenarios, while prioritizing patient safety, data integrity, and business risk. • Establishing Written Standards and Controls: Participating in the implementation of new standard operating procedures (SOPs). Leading the process more »
conducting, and reporting audit activities. You will provide responsive and proactive quality and compliance advice to collaborators, effectively influence assigned area by being relevant GxP/quality system expert, and support regulatory authority inspections when required. You will also lead training for colleagues and business collaborators as required, promote a …/or revision of QA processes, projects and tools, communicate effectively with QA colleagues and business collaborators, maintain knowledge of relevant industry information affecting GxP quality and compliance, support quality and compliance risk management for functional area, and travel as expected. Essential Skills/Experience: Audit experience in pharmaceuticals or … continuous learning and adaptability to the changing technological and regulatory landscape Desirable Skills/Experience: Project management experience Experience in managing regulatory health authority GxP Inspections Key Account management Audit expertise When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life more »
the TA/Business area point of contact for the Global Quality Head and attend Quality LT meetings as required Has accountability for ensuring GxP compliance across the TA/Business area ensuring implementation and maintenance of the QMS. Ensures no interruption to the supply of medicines to patients for … Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. Leaders with accountability for GXP areas are expected to understand their roles' legal and regulatory requirements in providing appropriate resources (human, financial, material, facilities, and equipment) to maintain the Quality more »