4 of 4 GxP Jobs in the East of England

techniques (essential) Knowledge of M10 method validation guidelines for PK assays or FDA guidelines for Immunogenicity. (essential) Project management experience (desirable) Experience in a GXP accredited laboratory (desirable more »

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 »

ensuring a clear understanding of objectives and deliverables. Oversee and contribute to the writing, reviewing, and approval of technical and validation documents to ensure GxP compliance. Conduct both informal and formal test executions to verify system functionality against business requirements. Work closely with the Tech Product Manager to maintain alignment … with the Test Lead to support test planning and execution. Required Experience & Knowledge: Deep knowledge of clinical and manufacturing processes, particularly within a regulated (GxP) environment. Proven experience with Manufacturing Execution Systems (MES) and electronic Batch Records (eBR) , preferably within the pharmaceutical or life sciences industry. Strong understanding and experience … with GxP validation documentation processes. Familiarity with Agile ways of working (Agile WoW) and project management within Agile environments. Soft Skills: Excellent communication skills to interact effectively with both technical and business stakeholders. Strong organizational skills with the ability to prioritize tasks effectively. Detail-oriented with a focus on quality more »

Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/… process. Flexibility and adaptability in a changing regulatory environment. Education, Experience & Skills Required · Direct experience in leading, managing or participating in CSV projects in GxP environments. · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). · Extensive experience in … regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. · GLP/GCP/GMP experience is preferable. · Experience in supporting regulatory inspections. more »