1 to 25 of 150 GMP Jobs

Team Leader and continue to always perform as a leader within the group. You will work according to all necessary Good Manufacturing Practice (GMP), Hygiene and Health & Safety (H&S) requirements to ensure high quality products are produced in accordance with standard operating procedures (SOPs) and regulatory requirements. You will … make sure these are covered off in an acceptable and timely manner. Ensure all activities are conducted in compliance with Good Manufacturing Practice (GMP) standards Complete and review all documentation in a timely manner and ensure accuracy is maintained in line with batch right first-time targets (BRFT) Drive ...

user requirements gathering, risk assessments, validation planning and test execution. Maintain documentation including SOPs, validation records, configuration specifications and change records. Ensure compliance with GMP, GAMP 5, Annex 11, 21 CFR Part 11 and company quality procedures. Support internal audits, external audits and regulatory inspections. Project and Vendor Management Work ...

skills. - Experience dealing directly with customers on quality matters. - Excellent communication and stakeholder management skills. - The ability to work independently while managing multiple priorities. - GMP experience (desirable). - Degree or equivalent in a science, engineering or manufacturing discipline (desirable). This is an excellent opportunity for an experienced Quality Assurance ...

endpoint management solutions Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical and troubleshooting skills ...

engaging and dealing project stake holders and work cross functionally. (E) An Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines (E). Validation project management (P) Familiarity of SaaS/Cloud based systems validation utilising modern CSA approach. ...

ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines. ERP & System Expertise: Work hands-on with ERPs, eDMS, eQMS, LIMS, laboratory ...

other advanced planning systems Knowledge of dairy co-operative operations and seasonal demand patterns Understanding of food safety regulations (SQF, HACCP, GMP) Experience implementing process improvements or system enhancements COMPETENCIES: Analytical Thinking: Ability to interpret data, identify trends, and make data-driven decisions Communication: Strong written and verbal communication skills ...

Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

similar enterprise platforms) and how to organize and execute cross-functional projects related to their implementation Understanding of FDA requirements for validated systems, including GMP/GxP, ISO 13485, FDA 21 CFR Parts 11 and 820, and electronic records/e-signatures compliance Excellent leadership, communication, and stakeholder management skills ...

teams needs, challenges and requirements. Develop strategies to leverage Salesforce Media Cloud for centralizing and monetizing ad inventory across platforms like Google Marketing Platform (GMP); Meta Ads; Criteo and LinkedIn and more. Provide expert advice on best practices for ad operations, inventory optimization, and revenue growth. Implementation and Configuration Lead ...

Investigational Medicinal Product (IMP) manufacturing and associated Quality Management Systems at MedPharm. The role is responsible for supporting compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), applicable regulatory requirements and internal quality procedures through the review of quality documentation, management of quality systems … analytical methods, sampling instructions and protocols. Support review of analytical investigations including OOS, OOT and atypical results. Review laboratory documentation to ensure compliance with GMP, GLP and internal procedures. Support QA oversight of reference standards, retained samples and stability documentation where applicable. Materials Management Perform QA review and disposition ...

problem-solving skills. Good IT skills, including Microsoft Office and MRP/ERP systems. Desirable 5+ years' mechanical inspection experience. Knowledge of FDA, GMP and ISO 13485 standards. Engineering qualification, apprenticeship, or equivalent industry experience. Experience working within regulated manufacturing environments. Key Skills CMM Programming & Inspection (Essential) LK & Mitutoyo CMMs ...

site is audit-ready at all times. Maintain accurate quality records & contribute to the reporting of site quality KPIs. Manage the site's GMP auditing programme & actively participate in the internal audit team. Drive continuous improvement initiatives that enhance product quality, food safety and operational performance. Ensure Health & Safety, Hygiene ...

operations Excellent knowledge and understanding of Lab systems, Lab data, and the workings of a lab on a day-to-day basis in a GMP environment (Pharma or Consumer Health Care business). Understanding and experience in the deployment of key lab digital systems (e.g. QC E-planning, QC Electronic ...

will be critical as you contribute to process innovations and operational excellence. Here’s What You’ll Need 3+ years of experience in a GMP manufacturing environment This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. ...

faulty material. When required support sorting activity. Conduct where appropriate, testing of raw material. Carry out internal audits to the standards - Monitor and maintain GMP/BBQ. G&P, Internal audit performance. Publish results, raise and manage non-conformances. Oversee and conduct quality inspection rounds during the designated shifts. Monitor ...

Role Accountabilities • Deliver a risk-based programme of internal and supplier audits to assess compliance with food safety, quality, legality and customer standards • Evaluate GMP, hygiene, HACCP, allergen controls and traceability during audits to ensure sites meet required standards • Plan, conduct and report audits independently across multiple categories, processes ...

Cambridge, Waterbeach site! As the Senior Quality Engineer, you will support the development and manufacture of innovative instrumentation and single-use consumables for GMP cell and gene therapy manufacturing, as well as research use only (RUO) applications. Working closely with Engineering, Manufacturing, and the broader Quality team, you will provide ...

Cambridge, Waterbeach site! As the Senior Quality Engineer, you will support the development and manufacture of innovative instrumentation and single-use consumables for GMP cell and gene therapy manufacturing, as well as research use only (RUO) applications. Working closely with Engineering, Manufacturing, and the broader Quality team, you will provide ...

Oriented Programming Git version control Basic electrical, mechanical and pneumatic knowledge Robotics Machine Vision SCADA/MES systems Pharmaceutical or regulated manufacturing environments GAMP, GMP, 21 CFR Part 11 or EU Annex 11 Industrial communication protocols including EtherCAT, Profinet, CAN, Ethernet/IP and Serial communications .NET ...

Experience with industrial automation systems and OT architecture, including integration with IT systems Familiarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511 Understanding of cyber security risk assessments, controls, and system documentation Experience in system lifecycle management, including validation, change control ...

execute commissioning, qualification, and SAT protocols. Prepare system impact assessments, qualification documentation, and validation reports. Review project documentation for technical accuracy, compliance, and GMP requirements. Ensure systems are safe and ready for start-up, testing, and qualification activities. Perform installation verification, system start-up, and functional testing. Monitor progress, coordinate ...

execute commissioning, qualification, and SAT protocols. Prepare system impact assessments, qualification documentation, and validation reports. Review project documentation for technical accuracy, compliance, and GMP requirements. Ensure systems are safe and ready for start-up, testing, and qualification activities. Perform installation verification, system start-up and functional testing. Monitor progress, coordinate ...

PowerPoint A proactive approach to problem solving, risk management and decision making Desirable criteria include PRINCE2 or PMP certification Experience working within a GMP or regulated environment Experience delivering projects across multiple global locations Experience managing third-party suppliers and external resources Experience communicating with senior leadership and executive stakeholders ...

quality systems are adhered to, support investigations, conduct audits and help drive continuous improvement initiatives across the site. Key Responsibilities Conduct internal audits covering GMP, hygiene, traceability, product quality, documentation and manufacturing processes, ensuring corrective actions are completed effectively. Investigate quality, food safety and compliance issues, including customer complaints ...