Skipton, North Yorkshire, Yorkshire, United Kingdom
Dechra Pharmaceuticals Limited
automation and information management systems To be familiar with product development, manufacturing, quality assurance and quality control systems To be able to write standard GxP documentation independently Must be able to deliver a range of QA training packages Expert knowledge of GMP standards Good knowledge of electronic quality systems Knowledge more »
also have Project management experience Practical laboratory experience and knowledge of lab techniques Knowledge of computer system validation and SAP validation An understanding of GxP best practices Quality risk management Experience with record keeping and change control management What we look for Highly motivated individuals with excellent problem-solving skills more »
environment and comfort with operating in situations with ambiguity and white space Robust understanding of the biopharmaceutical industry, clinical trial conduct, regulatory, safety and GXP Strong verbal, written communication and presentation skills Nice-to-Have Master's degree At least 4 years strategy or operational consulting experience Relevant pharmaceutical industry more »
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 »
MES PAS-X, Operations and Design. Relevant Pharma experience or another highly regulated industry, in relation to business processes. Understanding IT system lifecycle in GxP environment and IT system validation process. Are you? Good communicator/motivator/team player. Able to deliver high performance standards. If so - we would more »
empower employees to resolve common IT issues independently. Promoting compliance of all company policies, including adhering to Company data security policy. Complete all appropriate GxP/SOP training and adhere to all role specific SOP requirements. Skills & Experiences Strong problem-solving skills, with the ability to troubleshoot complex technical issues. more »
Product Owner | Greater Manchester | £55,000 - £65,000 Pharmaceuticals | Tech 4 Good | Biotech | Salesforce | Product Owner | GxP | Health Cloud | SFDC Are you a driven Product Owner with a passion for delivering high-quality products in regulated industries? Do you have experience navigating Good Manufacturing Practice (GxP) validation processes and ensuring … biotech firm who are at the forefront of innovation - as they continue to expand their portfolio of product they need a Product Owner with GxP validation experience to join the team and take their product development to new heights. Looking for a Product Owner with a strong understanding of GxP … FDA, and international regulatory guidelines for product validation and lifecycle management as well as experience in product development with a focus on GxP-compliant environments including system and software validation. Offering between £55k - £65k dependent on experience. Send a copy of your CV to (url removed) to find out more 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 »
