7 of 7 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 ...

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 ...

Familiarity with FDA and other international regulatory requirements for medical device and pharmaceutical GxP system software (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). Proficiency in various programming languages, such as C++, Java, or Python, and experience with software development tools, such as version control systems ...

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 ...

Must Have's: Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment. Familiarity with ISA 88, GAMP, cGAMP Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, automation C&Q activities. RESPONSIBILITIES Responsible for Software Development in DeltaV platform Conduct and oversee … manufacturing setting for Life Science industry Understanding of Process Automation implementation in a Pharma/Biotech environment. Familiarity with ISA 88 and GAMP Demonstrated skill with scripting and test automation. Clear understanding of Software Development Life Cycle (SDLC) and Agile methodologies. Qualifications Bachelor's or Graduate's Degree in engineering ...