9 of 9 GAMP Jobs

process validation, equipment qualification.Develop validation master plans, protocols, risk assessments, and reports.Ensure regulatory compliance with FDA 21 CFR Part 11, GAMP 5, ISO 13485, and other standards.Partner with engineering, manufacturing, QA/QC, and operations teams to ensure validated state.Perform gap assessments, audits, and remediation of validation documentation.Oversee change control ...

just use them, you understand how they work and why they matter You have a solid understanding of related guidelines (GAMP 5 (ISPE), USFDA 21 CFR Part 11 en Eudralex Annex 11) and know how to apply them in a regulated environment You are detail-oriented by nature, curious ...

ensure successful implementation of smart factory and digital transformation initiatives. Ensure all solutions comply with relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5) and industry best practices. Client Engagement & Advisory: Act as a trusted advisor to clients, translating business challenges into actionable technical solutions. Conduct workshops, technical assessments ...

compliance. Your Profile Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. ...

compliance. Your Profile Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. ...

translate complex technical concepts into clear business value Experience with Agile methodologies and product management tools (e.g., Jira, Aha!, Confluence) Familiarity with ISA-95, GAMP 5, and other industry standards Experience working with cloud-based MES platforms and integration with ERP/LIMS systems Familiar to work in a multicultural ...

software applications and web services using PI-SDK and AF-SDK Experience installing and configuring web-based applications. Requirements: Familiarity with ISA 88 and GAMP Minumim over 5+ years relevant industry PI experience Pharma industry experience perferred but not essential PI System Training Bachelor's Degree in appropriate field ...

compliance with internal procedures. Assist in developing user requirements and functional specifications for computerized systems used in GxP environments. Ensure validation activities follow GxP, GAMP, SDLC, and 21 CFR Part 11 requirements. Support issue resolution, change management, and related IT/Quality processes. Perform additional related duties as required. Required … ability to interact effectively with both technical and non-technical stakeholders. Solid interpersonal and teamwork abilities; strong client focus. Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, and good documentation practices. Experience with pharmaceutical or biologics manufacturing systems, laboratory systems, and clinical manufacturing environments. Understanding of MES platforms ...

work within a flexible, multi-skilled team to design, test, and implement PLC and SCADA/HMI solutions — ensuring compliance with GxP and GAMP standards. This hands-on position combines software design , system integration , and field service/commissioning both in the UK and internationally. Key Responsibilities Provide service, software … control systems for upgrade and retrofit projects. Manage data communications with third-party equipment and systems. Validate and document software designs in line with GAMP and pharmaceutical standards. Promote and implement Syntegon Telstar standard design practices to improve efficiency and cost-effectiveness. Provide remote and onsite technical support , including troubleshooting ...