1 to 25 of 135 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. ...

data flow issues. Compliance & Documentation Maintain documentation for MES configurations, SOPs, workflows, validation protocols, and system changes. Support compliance with FDA, USDA, HACCP, SQF, GMP, and internal quality standards. Participate in change management, system testing, validation, and deployment activities. Assist with user training and development of work instructions. Required Qualifications ...

management Audit trail review IT supplier and cloud service provider management Make sure IT procedures meet regulatory expectations, especially 21 CFR Part 11, EU GMP Annex 11, the MHRA GxP Data Integrity Guidance and GAMP 5 (Second Edition). Document the controls that keep GxP systems in a validated state ...

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 ...

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 ...

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 ...

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. ...

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 ...

time. To manage internal taste panel and shelf-life sample assessments. Assist in the management and completion of internal audits including CCP, GMP, fabrication, hygiene, plastic, and system audits. Skills and Experience Required Relevant certification - HACCP Level 3 Basic Food Hygiene Attention to detail and able to prioritise workload. Organised ...

root cause analysis. Support supplier approval processes and supplier questionnaires. Ensure quality control equipment is calibrated and maintained. Promote continuous improvement, quality culture and GMP standards. Deliver quality-related training across site where required. Essential Skills & Experience Previous experience within a manufacturing environment. Knowledge of quality systems and food safety ...

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 ...

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 ...

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 ...

experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data ...

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 ...

conformance, customer complaint investigations, glass & plastic audits, and fabrication audits. - Supporting the training of staff and verification against CCPs, policies and procedures. - Conducting internal GMP audits across departments and conducting hygiene verifications. - Assisting with external audits. The role will be a mix of factory and office-based work to meet ...