SVT COMPLIANCE LEAD
Descripción de la oferta de empleo
Ensures SDLC, ASLM, FDA, and SOX compliance for IT Projects in every portfolio.
The position will define and analyze system needs\/problems; design and test standards and solutions, create SDLC documentation, and ensure validation documentation meets requirements *CV must be sent in English* Essential Functions Performs and oversees software project validation in line with departmental SOPs and guidelines.
Ensures SDLC validation documentation content is complete, maintained and meets GxP\/FDA requirements.
Authoring and\/or contributing to all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
Assesses company's computer systems and identifies any potential GxP or FDA Part 11 gaps Participates in regulatory audits and provides information on validation activities performed for Q2 computer systems.
Providing standardized templates, guidance, and overall validation direction supporting various programs Reviews internal and external requirements and implements required processes as needed to meet expectations regarding Quality All other System Validation Team processes and tasks as needed Qualifications Bachelor's Degree in Computer Science, a related field or equivalent experience in a medical, clinical, pharmaceutical or analytical setting Over Five (5) years related experience in Software Validation in a medical, clinical, pharmaceutical or analytical setting Excellent communication skills in English Experience with FDA, GxP, Part 11 and SOX validation rules and regulations Ability to travel to Q2 Solutions sites for in-person audit support as required Desired Technical Abilities HP ALM HP Quality Center Jira Software Validation SDLC Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
https.
/\/q2labsolutions.
om\/careers ","applicantLocationRequirements".
{"@type":"Country","name":"MX
Detalles de la oferta
- English
- En todo México
- Sin especificar - Sin especificar
- 21/10/2024
- 19/01/2025
Be able to lead by example... we lead with respect and honesty: - we build trust through transparency... lead the identification, innovation, and implementation of new tools and processes to support this work scope... lead the identification, coordination, and communication of software requirements,......
We excel in lead generation through fb webinars, seo, and google ads... a small oversight can lead to significant consequences, so meticulousness is a must... remote flexibility: work from anywhere in the world and connect with our international team... com/to/hmsg7wxo(please note: you must be physically......
I am thrinadh, i work as a technical lead recruiter for cliecon solutions inc... net) strong experience in customization and configuration strong knowledge data migration and power platform integration good experience with security and role-based access control ms dynamics 365 – f&o; – finance functional......
Provide status reports to your engagement manager, technical lead or supervisor, keep them apprised of overall project situation... exceptional research skills and resourcefulness... engineering, computer science or computer information systems preferre fluent language skills in spanish and english......
Provide status reports to your engagement manager, technical lead or supervisor, and keep them apprised of the overall project situation... exceptional research skills and resourcefulness... professional career projection... (or related) fluent language skills in english... you must have a good understanding......
Candidate should have good communication skills, be a team player and be able to lead a team... requisitos del puesto good knowledge of the tandem platform architecture good knowledge of cobol85, c and tal programming languages good knowledge in programming with pathway middleware......
Candidateshould have good communication skills, be a team player and be able to lead a team... we are looking for an enthusiastic and motivated “senior unisys developer” in our development team... requisitos del puesto good knowledge of the unisys platform architect good knowledge of cobol and algol......
This is an exciting opportunity lead in the development of the clients operations in central and south america... they should be familiar with different grades, polymers and regrinds, and have an established network of suppliers... the client has established themselves across europe and has had success......
Team lead (jefe de equipo) está con usted 24/7 y siempre le apoyará... horario de trabajo flexible con fines de semana flotantes, turnos de 8 horas + 1 hora de descanso remunerado... y nuestra cobertura geográfica abarca más de 50 países diferentes en américa latina, europa, asia y oriente medio......
Lead training sessions: conduct remote web sales training and travel to regional partner locations for training events desired skills & experience: extremely organized: structurally-minded; able to balance/prioritize tasks/projects simultaneously, always looking to improve efficiency......
