Vaga de Validation lead -senior

Somos a Tech Mahindra, empresa do Grupo Mahindra, uma multinacional Indiana e está presente no Brasil e em 90 países. Somos mais de 120.000 profissionais que nos ajudam a conectar experiências. A Tech Mahindra representa o mundo conectado, oferecendo experiências de tecnologia da informação inovadoras e centradas no cliente, permitindo que empresas, colaboradores e a sociedade cresçam. Nós realmente acreditamos que a tecnologia torna isso possível, mas são as pessoas que fazem isso acontecer. Diversidade Cultural, de Gênero e de Habilidades se alinham nos nossos pilares do Rise e nos permite "Diversidade de Pensamentos", que capacita nossos stakeholders a crescer. Configuration Specialist - Senior Job Description Ï Collaborate closely with Product Owner, Scrum Master, Architects, Configuration Specialists and Tester Team (Leads) Ï Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems Ï Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance Ï Provide estimates and forecast validation activities for a project Ï Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life Ï Determine testing strategy, requirements and acceptance criteria Ï Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards Ï Coordinate and advise on all validation activities on a global level/organizational level for system/project Ï Participate actively in validation discussions, provide consultancy for all validation related questions Ï Participate in system implementation and maintenance planning Ï Lead and author system and functional risk assessments Ï Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions Ï Review and collect expected CSV deliverables, records and other evidences according to plans Ï Prioritize activities in line with the project schedules, business needs and compliance requirement Ï Ensure code release to production and maintenance procedures are identified and adhered Ï Confirm initial data loading and/or data migration from other systems, are performed according to approved procedures Ï Assess changes to determine potential impact to the validated state of the computerized system Ï Support system maintenance with validated state and permanent audit readiness Ï Lead and author system periodic review according to procedure Ï Observe governance processes, escalates area for improvement Ï Support system audit/inspection preparation and execution as CSV subject matter expert Ï Assures strategic/essential oversight over validation support within the department and provides support/consultancy for the team and within the global organization if necessary. Ï Implements relevant framework and processes, propose and uses tools Ï Providing training and validation/quality knowledge/experience exchange support Ï Prepares recommendations for process optimization in his/her area of influence. Ï Provide input and guidance for a computerized system retirement planning Ï Demonstrates proficiency in gSuite Ï Demonstrates basic knowledge of SAP and MES systems and the interfacing thereof Ï Demonstrates ability to explain complex concepts with clarity and simplicity Ï Demonstrates ability to perform detail-oriented work with a high degree of accuracy Ï Demonstrates strong verbal, written, and interpersonal communication skills. Skills Ï 3 years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment Ï Mandatory Experience in Lean and/or Agile approaches Ï Experience in leading validation for projects and systems maintenance Ï Experience in authoring validation plans, reports and deliverable registries Ï Experience in authoring or reviewing validation related deliverables, records and other evidences Ï Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated) Ï Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11 Ï Aware of common development technologies and governance processes impacting validation approaches Ï Ability to work collaboratively in cross-functional teams to achieve milestones and goals Ï Ability to communicate clearly and professionally both in writing and verbally Ï Ability to share knowledge and guide others Ï Ability to make sound decisions about quality and technical subjects Ï Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry Ï Communication skills, English language mandatory (C1) Ï Assertiveness, conflict management skills, leadership skills Ï Hands-on experience with Retina or JIRA (Backlog) Ï Hands-on experience with ServiceNow (Incident, Change, Knowledge Management) Ï Professional Scrum or SAFe Certification is an advantage (will be mandatory after joining) Informações adicionais: Configuration Specialist - Senior Job Description Ï Collaborate closely with Product Owner, Scrum Master, Architects, Configuration Specialists and Tester Team (Leads) Ï Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems Ï Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance Ï Provide estimates and forecast validation activities for a project Ï Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life Ï Determine testing strategy, requirements and acceptance criteria Ï Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards Ï Coordinate and advise on all validation activities on a global level/organizational level for system/project Ï Participate actively in validation discussions, provide consultancy for all validation related questions Ï Participate in system implementation and maintenance planning Ï Lead and author system and functional risk assessments Ï Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions Ï Review and collect expected CSV deliverables, records and other evidences according to plans Ï Prioritize activities in line with the project schedules, business needs and compliance requirement Ï Ensure code release to production and maintenance procedures are identified and adhered Ï Confirm initial data loading and/or data migration from other systems, are performed according to approved procedures Ï Assess changes to determine potential impact to the validated state of the computerized system Ï Support system maintenance with validated state and permanent audit readiness Ï Lead and author system periodic review according to procedure Ï Observe governance processes, escalates area for improvement Ï Support system audit/inspection preparation and execution as CSV subject matter expert Ï Assures strategic/essential oversight over validation support within the department and provides support/consultancy for the team and within the global organization if necessary. Ï Implements relevant framework and processes, propose and uses tools Ï Providing training and validation/quality knowledge/experience exchange support Ï Prepares recommendations for process optimization in his/her area of influence. Ï Provide input and guidance for a computerized system retirement planning Ï Demonstrates proficiency in gSuite Ï Demonstrates basic knowledge of SAP and MES systems and the interfacing thereof Ï Demonstrates ability to explain complex concepts with clarity and simplicity Ï Demonstrates ability to perform detail-oriented work with a high degree of accuracy Ï Demonstrates strong verbal, written, and interpersonal communication skills. Skills Ï 3 years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment Ï Mandatory Experience in Lean and/or Agile approaches Ï Experience in leading validation for projects and systems maintenance Ï Experience in authoring validation plans, reports and deliverable registries Ï Experience in authoring or reviewing validation related deliverables, records and other evidences Ï Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated) Ï Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11 Ï Aware of common development technologies and governance processes impacting validation approaches Ï Ability to work collaboratively in cross-functional teams to achieve milestones and goals Ï Ability to communicate clearly and professionally both in writing and verbally Ï Ability to share knowledge and guide others Ï Ability to make sound decisions about quality and technical subjects Ï Higher education degree or relevant work experience in computer science, software engineering, information systems and/or pharma industry Ï Communication skills, English language mandatory (C1) Ï Assertiveness, conflict management skills, leadership skills Ï Hands-on experience with Retina or JIRA (Backlog) Ï Hands-on experience with ServiceNow (Incident, Change, Knowledge Management) Ï Professional Scrum or SAFe Certification is an advantage (will be mandatory after joining)