1 to 25 of 27 GxP Jobs in England

SAP B/W4 HANA, SAP Datasphere. Ability to lead across geographies and cultures. Desirable Qualifications: Leading multiple teams across geographies. Regulatory experience, e.g. GxP and SOx. Exposure to S/4 HANA Central Finance implementations. Exposure to SAP Finance, Controlling, and integration of finance with other SAP areas like more »

operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP). Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an more »

Actively contribute to the Quality mission to design & develop a single, fit for purpose QMS. Conduct GCP process, vendor, and investigator site audits. Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV. Requirements: Strong GCP Quality experience in biotech/pharma which spans clinical more »

as indicated in applicable controlled documents, are followed Perform other duties, as assigned by management Minimum Required: 8 years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to interpret applicable regulations/standards Experience in leading process improvement initiatives Ability to 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 »

issues. Work in close collaboration with Global Regulatory Leads and subject matter experts to ensure clinical trial deliverables are executed. Support internal and external GxP inspections. Leads project teams effectively to escalate and drive resolution of project issues. Effectively frames complex issues for decision-makers. Supports the Associate Director with more »

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 »

or Pharmacy) or technical (Engineering) or significant relevant experience working within the Pharmaceutical Manufacturing Industry in an Operations environment Experience within a pharmaceutical/GxP environment in technical operations. Experience in the technical transfer, scale-up and process validation of equipment and processes Proven ability to work effectively on own more »

installation and commissioning of assets. Good Manufacturing Practices (GMP) are employed, including activities determined from user requirement specifications (URS) through to qualification. Approval of GxP documentation, including technical specifications, user requirements, design/code reviews, qualification protocols and site acceptance testing. Quality and engineering change controls to maintain the validated 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 »

be beneficial to your application, but is not essential: Bachelors degree (or equivalent) in a scientific or technical discipline Worked within a pharmaceutical/GxP environment in a Quality related role Familiarity with the production of solid dose oral products Management of electronic & physical documentation systems Reward For the successful more »

small molecule drugs, which is highly advantageous. Exhibit thorough knowledge of safety regulations in both EU and US contexts. Display a strong grasp of GxP guidelines pertaining to drug safety. Demonstrate a proven capacity to work autonomously while effectively prioritizing tasks, with a collaborative spirit and commitment to compliance. Showcase 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 »

teams to service the client) Good understanding of the Life Sciences or Consumer Goods industry Appreciation of the requirements of operating in regulated environments (GxP, SOX) Excellent communication skills Results driven Building relationships and strengthening partnerships by focusing on exceptional client experience Concepts of financial, marketing and business strategy Business more »

Understanding of the drug development industry and HS&E in a life science setting. Laboratory Exposure: Extensive experience working in a lab environment with GxP experience. Qualifications : An undergraduate degree in science and H&S qualifications are highly desired. Why wait? The time is now! Dont let this opportunity pass more »

Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations and fostering a culture of data integrity. You'll serve … as the Data Integrity SME and contribute to maintaining and developing QMS related to IT. Key Responsibilities: Ensure ongoing compliance of GxP IT systems and processes. Support adherence to GMP/GDP and GCP regulations, including data integrity legislation. Act as System Owner/Administrator for GxP IT systems within … QA. Lead Computer System Validation and compliance processes. Review and lead compliance efforts for GxP IT system-related change controls. Provide coaching and support for data integrity adherence. Conduct periodic reviews of data integrity documentation. Assist in other quality systems as needed, such as Non-Conformances and CAPA. Collaborate with more »

in this location. Key Responsibilities: For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation. Serve as the System Owner/Administrator role for GxP IT systems that reside within QA. The ideal candidate will carry … data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to GxP impact and GxP compliance of … of pertinent change controls. Any other assigned duties. Requirements: Experience with TrackWise, LIMS and Documentum and/or any other QMS systems. Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK. Familiarity within a pharmaceutical manufacturing, testing or quality assurance setting in a similar position. Prior more »

a globally recognised market leader in their space to recruit a Qualified Person (QP) for their site in the North of England. Responsibilities: Defining GxP protocols and benchmarks for the facility in conjunction with the divisional Quality unit and external stakeholders, overseeing gap analyses, and spearheading enhancement initiatives as needed. more »

Summary Dechra Pharmaceuticals are looking for an experienced auditing professional to join our manufacturing division on a remote basis. Support the GxP and Regulatory compliance of Dechra Products by developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product lifecycle. Develop, approve … and monitor the risk based GxP audit programme and budget for Dechra DPMS. Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully conclude regulatory inspections for Dechra's products. Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for … and review or preparation of responses to deficiencies) and on-site presence as required. Develop audit systems to ensure key elements of the Dechra GxP Quality Management System and the requirements of the product licences/marketing authorisations are effectively implemented throughout the internal and external manufacturing network (as required more »

formal qualification in core engineering discipline/secondary engineering discipline is desirable Broad based knowledge and interest in engineered systems and maintenance Understanding of GxP principals Knowledge of Temperature, humidity and pressure instrument loops, supporting BMS monitored HVAC, reactor systems, stability chambers/cold rooms and room pressure cascades. Experience … Engineering Workshop Supervisor to ensure all maintenance PM plans remain relevant, are technically correct and compliant. Ensure all documentation of maintenance activities are to GxP standards both in paper-based records and the Computer Maintenance Management System and that accurate reports are generated. Work on small projects where required, including more »

review prior to ǪP release o manage Product Specification Files for ATIMP’s o complaint and recall handling • Develop, review, and approve Ǫuality and GxP related documentation. Technical Requirements • Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to ǪP review … to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met. • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic requirements for sterile products • Extensive knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell more »

day to day activities such as CAPAs, deviations, change controls and supplier qualification. 2. Make sure that the CMO batch documentation are compliant to GXP standards, including the review of GMP documentation. 3. You will work closely with the Quality Specialist, and assist in regulatory inspections and customer audits. 4. … practical experience with document/Quality Management Systems, and Electronic Document Management Systems Key Words: QA | Quality Assurance | QMS | Quality Management Systems | Clinical | GMP | GxP | Biotechnology | QDM | Quality Document Management Systems | Electronic Document Management Systems | Drug Discovery | CAPA | Deviations more »

We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from home and … for leading the output from a team of QSHE people based in the region. Key responsibilities and activities Successful client and regulatory audits of GxP activities across the EMEA sites. Timely reporting and investigation of quality and safety related incidents and audits. Added value to the business through implementing efficient … working on other Global Pharmaceutical accounts. The group is responsible for conduct of audits, training, and quality/safety investigations, all of which ensure GxP and SHE regulations are satisfied. This position is home based, however travel is expected within EMEA to visit the relevant client sites. Essential Solid grounding more »

Key Skills: C-Level Business and Administration Support, CXO support, GxP, Sox, Office, video collaboration and broadcast solutions Xcede are currently supporting a leading FMCG company who are undertaking multiple transformation programs and require a Support Analyst/Consultant who can be the conduit between CXO stakeholders and their admin … customer relationship management. * Good project and time management skills. * Excellent analytical skills. Preferred Qualifications * Excellent negotiation skills. * Experience working in a regulated environment e.g. GxP, Sox. Please note that C-Level support experience is mandatory, so if you offer the above skills then please provide a copy of your CV more »

Manage elements of the PQS pertaining to cellular therapies manufacture, including document control, risk management, training, and audits. Develop, review, and approve Quality and GxP-related documentation. Lead risk assessments and investigations as required. Approve equipment, materials, and services for site use. Conduct external audits as necessary. Provide strategic input … ATMP manufacture preferred. Demonstrated leadership of small QA teams. Proficient in providing scientifically sound, risk-based quality advice. Extensive experience in writing and reviewing GxP documents. Strong knowledge of GMP principles, sterile production, and regulatory requirements for cell therapy products. Experience in generating and utilizing quality metrics. Educational Requirements: University more »