TRABAJO VALIDATION QUALIFICATION

You have experience in computer system validation... as qualification & validation specialist:you have an academic background related to areas such as pharmacy,...

qualification of visual inspection sets... maintain the archive of validation documentation... management of quality systems (deviations, change control, capa plans…)...

Computerized system validation (cqv, csv)... define, execute and document qualification tests... in syspro automation we are looking for engineers with experience...

Knowledge of digital validation platform (e... champion the adoption of risk-based qualification projects and e2e c&q digital validation ensure alignment with...

Guide validation activities, oversee project execution, and ensure timely delivery of validation deliverables... innovative design review:** overseeing new facilities'...

During health authority inspections and audits s/he is the first point of contact for computer validation related matters and in a leading role to ensure successful...

Tasks :    definition of validation strategies... generation of validation documentation (validation plan, risk analysis, qualification protocols: iq, oq, pq, reports)...

Provide technical expertise on procedures and validation master plan revisions... develop validation protocols based on available literature, company procedures...

Develop validation protocols based on available literature, company procedures, guidelines, and regulations... coordinate with other departments and implement all...

)working as a seconded resource in a client-siteto support and/or lead validation projects and activities on site, as directed and as appropriateto prepare validation...

Assist with establishing validation and /or qualification policies... provides end user support by software validation throughout the software validation life cycle...

Produce audit qualification reports, as appropriate, and review process validation reports... ensure that appropriate compliance documentation is put in-place, such...

Knowledge in active rf and in firmware integration and validation... ability to manage schedule and cost of integration and validation activities...

Collaborate in the definition of the tests of the equipment, facilities, and/or processes to be qualified/validated together with the eqa manager and the project...

  serve as validation lead in compliance with respective sops, ois and best practice documents...   ability to work in cross functional teams  experience...

) within studies   support implementation of data provisioning for usage in studies for clinical trial reporting with appropriate data models  ...

Perform execution of equipment qualification, fixture qualification (iq/oq), test method validation (gage r&r), and non-product software validation (npsw)...

Key objectives/deliverables: project management: lead and manage large capital projects ($5mm to $100+mm) consisting of both lilly and non-lilly professionals to...

Qrqc) execution of changes to the product, (if applicable) contribution to 1st train(s) /products manufacturing feedback to support functions in order to improve...

Support operational readiness, process validation and technology transfer activities up to approval by the applicable regulatory agencies (ie...