1 to 25 of 54 GMP Jobs

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 ...

accountable approach to documentation, testing and delivery. Beneficial experience Working knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11. Experience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports. Familiarity with manufacturing ...

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 ...

preventive action initiatives Maintain and verify pest control, traceability, recall, food defense, allergen control, and prerequisite programs Coordinate and deliver food safety, HACCP, GMP, and quality training programs for plant personnel Oversee laboratory operations, environmental monitoring programs, scientific testing, and corrective action activities Partner with cross-functional teams to ensure ...

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 ...

Computer Software Assurance), qualification, risk-based validation, and change control processes. Requirements: The candidate should have strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical or manufacturing environments. The candidate must possess knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA ...

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 ...

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 ...

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 ...

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 ...

system integration Experience with requirements engineering, risk management, design reviews, and V&V processes Regulated environment experience is a strong advantage Knowledge of GMP principles and/or bioprocessing applications is preferred Ability to make complex trade-offs and communicate effectively with stakeholders Strong analytical and problem-solving skills Excellent ...

leading Computerized System Validation (CSV) programs for regulated environments. Demonstrated expertise with SAP S/4HANA validation, governance, implementation, or support. Strong background in GMP Quality Assurance and Quality Systems oversight. Experience establishing and operating IT Governance frameworks. Experience supporting regulatory inspections and audits by FDA, EMA, PMDA, MHRA, NMPA … authorities. Fluent in English with excellent verbal and written communication skills. Technical Knowledge GAMP 5 (2nd Edition preferred) FDA 21 CFR Part 11 EU GMP Annex 11 Data Integrity and ALCOA+ principles ICH Quality Guidelines Risk-based Validation methodologies Quality Management Systems (QMS) SAP S/4HANA ERP platforms ...

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 ...

seeking an experienced Technical Architect to support a large-scale enterprise device migration and workplace transformation programme, within a highly regulated pharmaceutical GMP environment. The role will define, guide, and assure the end-to-end architecture across infrastructure, identity, networking, and security domains within a complex enterprise environment. The successful ...

coach, develop and inspire technical teams. Desirable Experience within medical devices, healthcare technology or other safety-critical industries. Knowledge of IEC 62304, ISO 13485, GMP and FDA-regulated environments. Experience with cloud platforms such as Azure, AWS or GCP. Understanding of cybersecurity for connected devices and IoT systems. Exposure ...

MedPharm Ltd in Guildford is seeking a CSV Specialist to govern and manage validated computerised systems (GxP) across the site, ensuring compliance with EU GMP Annex 11 and MHRA guidance. You will oversee the validation lifecycle (URS, IQ/OQ/PQ, reports), assess updates, perform risk assessments, and support ...

collected for testing schedules and testing schedules are met Logging micro samples Accurate carrying out of positive release checks for all finished products GMP audits/Glass and plastic audits, including generation of improvement areas, completing database Ensure close outs of non-conformances Sampling and recording of finished product shelf ...

will have experience in raw materials, technical or quality roles within food manufacturing. Bringing a strong understanding of food safety, legality, allergens, HACCP, GMP and customer codes. Being confident working with technical systems, specifications and supplier documents. You will have good analytical skills and the ability to spot risks early. ...

senior stakeholders. Useful context, not a narrow pedigree. Experience in a regulated, safety-critical or high-reliability environment would be valuable. Life sciences or GMP experience is helpful but not essential. The leadership style we value You listen widely, then decide. You are direct, fair, calm under pressure ...

seeking a GxP IT Systems Engineer to support manufacturing operations at their Harwell site in the UK. This role involves ensuring compliance with GMP standards, providing IT support, and maintaining system integrity. The ideal candidate will have a Bachelor’s degree in a computer-related field and 3-5 years ...

European sites in Belgium and the Netherlands.The Computerised Systems Validation Specialist will ensure that all IT systems affecting Good Manufacturing Practice (GMP) are appropriately validated and remain in a validated state throughout their lifecycle. The postholder will report to the CSV Quality Manager.**Duties and Responsibilities:*** Maintain oversight … Plan and all associated validation procedures, ensuring that they remain accurate, current and aligned with applicable requirements.* Maintain an up-to-date inventory of GMP-critical computerised systems, including each system’s owner, intended use and current validation status.* Prepare validation documentation for GMP computerised systems, including risk assessments, regulatory ...

within a QA, Quality Assurance, or Quality Control role. Experience within the food manufacturing industry is essential. Good understanding of HACCP, Food Safety, and GMP standards. Strong attention to detail and excellent record-keeping skills. Confident communication skills and ability to work collaboratively. Ability to work independently and make informed ...