1 to 25 of 30 GxP Jobs in England

in alignment with business objectives.Delivery of medium and large site Capital Projects within budget and timelineManagement of project execution resources and vendorsDeliver projects with GxP and Cybersecurity complianceOversee the coordination and management of project execution resources, including internal teams and external vendorsMaintain continuous engagement with all project stakeholders through regular … updates and strategic meetings to ensure alignment and address concernsJob Requirements:Experience in project management within the pharmaceutical or related industry, particularly with GxP complianceProven capability in managing both IT and OT domainsAbility to understand complex applications and OT asset landscapeIn-depth knowledge of Data Integrity, BMS, EMS, and SCADA more »

Generics [U.K.] Ltd.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to 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 »

audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise, conduct, and support internal and external GxP audits · Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees · Maintain a tracking tool for audits … Quality System · Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective … training procedures in collaboration with other business companies and provide training in the area of expertise as assigned. 3. Inspections · Support the preparation for GxP inspections · Support the responses to Regulatory Authorities · Supervise and provide input to the corrective and preventive actions · Follow-up on the development, implementation and completion more »

platform for Pharmaceutical and Biotech customers. This is groundbreaking work, reinventing the MES concept. So, as well as knowledge and experience of MES and GxP IT projects, you absolutely must be open to working in new ways with a flexible and creative mindset in tight collaborative teams with colleagues and … customers. Factorytalk has unique experience and know-how in creating, building, and validating GxP Apps using this modern digitalization tool. You will receive extensive training on Tulip, attain certification, and additional training on Factorytalk’s specialist App design, building, and validation methods to deliver Tulip solutions for GxP use. This more »

Business Administrator for Veeva eQMS, oversee quality associated records and ensure these activities conform to regulatory requirements. Manage the controlled document scheme, act as GxP archivist, and deliver QA training activities. duties within Quality function. It is desirable, but not essential for the candidate to have a comprehension of basic … reports and dashboards in Veeva. Provide eQMS training to ensure competence across the business and maintain associated controlled documents. Ensure the appropriate storage of GxP documentation. Act as the primary company archivist by coordinating and preparing documentation for the offsite archive. Ensure appropriate process in place for the recall of … documents when requested. Administration of the quality assurance logs such as signature, notifications, QTA and audits. Document owner for GxP documents such as policies and the quality manual. Manage the controlled document scheme, including issuance and reconciliation. Provide information for Batch Record Review, QP certifications, Sponsor Release as and when 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 »

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 »

PMDA and other global regulatory agencies. Who We Are Zigzag Associates partners with companies across the entire drug discovery and development process to improve GxP Quality against global regulatory standards. We are a global, certified woman owned company who put people first and forge lasting relationships to bring deep impact 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 »

with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »

with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »

with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure 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 »

IT Team, reporting into the IT Automation Lead. This contract role will initially be until December 2024. Requirements: Data Integrity Knowledge Pharmaceutical Industry Experience (GxP) BMS, EMS and SCADA Systems Experience and Knowledge Knowledge of IT and OT areas Ability to understand complex application and OT asset landscape If you more »

is delivering impactful, practice-changing evidence and is recognised as a scientific leader. You will be responsible for ensuring compliance to the ABPI code, GxP requirements and other relevant regulations related to evidence generation activities are met. Essential Skills/Experience: Degree in epidemiology or life sciences (or equivalent) Experience 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 »

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 »

Role: • Support Achilles Quality Management System (Veeva). Overview: • Administer Veeva eQMS, maintain quality records, ensure regulatory compliance. • Manage Achilles controlled documents, act as GxP archivist, and deliver QA training. Profile: Essential: • Business Administrator for Veeva QualityDocs, eQMS, training. • Document management expert, audit representation. • Manage training, provide QMS data, maintain … reports. • Conduct eQMS training, oversee GxP document storage. • Administer quality logs, manage controlled documents. Desirable: • Basic Veeva configuration for troubleshooting. • Implement eQMS modules, new releases. 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 »

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 »

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 »

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 »

a track record in Leading the HSE function across multiple companies in a Pharmaceutical environment. It is key that you have experience within a GXP/GMP environment. Purpose of the Job Health, Safety & Environment Lead and provide oversight and Global strategic leadership covering health, safety, and environment across the 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 »