Talent.com

Empleos en Vega baja, vega baja

Última actualización: hace 4 días
IT CSV System Analyst

IT CSV System Analyst

ViatrisVega Baja, Puerto Rico, USA
At VIATRIS, we see healthcare not as it is but as it should be.We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers p...Mostrar másÚltima actualización: hace 8 días
Sandwich Artist

Sandwich Artist

Puerto RicoVega Baja, Puerto Rico, United States
As part of the Subway® Team, you as a Sandwich Artist ® will focus on four main things : .Providing an excellent Guest experience. Preparing and serving great food .Keeping restaurants clean and beaut...Mostrar másÚltima actualización: hace más de 30 días
Retail Sales Associate (Part-Time)

Retail Sales Associate (Part-Time)

AutoZoneVega Baja, Puerto Rico, United States
AutoZone's Part-Time Retail Sales Associates drive sales through superior customer service by exceeding customer expectations and providing a WOW! Customer Service experience.While assisting custom...Mostrar másÚltima actualización: hace más de 30 días
Automation Specialist III

Automation Specialist III

HR WorksVega Baja, Puerto Rico
Directly responsible for the execution of all automation assignments to fulfill our client's needs.Responsible for complex troubleshooting, and optimization for automation equipment, and applying a...Mostrar másÚltima actualización: hace más de 30 días
Product Tester - Fashion (remote)

Product Tester - Fashion (remote)

MediabistroVega Baja, Puerto Rico, United States
Get Paid to Test New Fashion Products from Home!.Are you passionate about fashion and love trying new styles? Our company is now recruiting individuals nationwide to participate in Paid Product Tes...Mostrar másÚltima actualización: hace 4 días
CSV Specialist

CSV Specialist

QRC Group, LLCVega Baja, PR, pr
To support the installation of several manufacturing solid dosage equipment such as but not limited to : .Main activities should include : . Verification of the equipment installed and configured at the...Mostrar másÚltima actualización: hace más de 30 días
Elder Care Provider Wanted - Elder Care Provider Needed In Vega Baja, Pr $11 / Hr Family Friendly Home

Elder Care Provider Wanted - Elder Care Provider Needed In Vega Baja, Pr $11 / Hr Family Friendly Home

ElderCare.comVega Baja, Puerto Rico, USA
Are you looking for a part-time, live out elder care job in Vega Baja? Nivia is a friendly family in Puerto Rico looking to hire a caring individual who can provide personal home care for our elder...Mostrar másÚltima actualización: hace más de 30 días
  • Oferta promocionada
Survey Taker : Earn up to $25 per survey (Remote)

Survey Taker : Earn up to $25 per survey (Remote)

Earn HausVega Baja, PR, United States
Looking for people to participate in taking online surveys for Fortune 500 brands.All you need to do is complete online surveys by sharing your opinion. You will help influence brand decisions on se...Mostrar másÚltima actualización: hace más de 30 días
Pastor Titular - ACM Oasis, Vega Baja, PR Job at The Christian and Missionary Al

Pastor Titular - ACM Oasis, Vega Baja, PR Job at The Christian and Missionary Al

The Christian and Missionary AllianceVega Baja, PR, United States
PASTOR TITULAR en una iglesia que goza de buen testimonio en la comunidad y denominación, con un ministerio saludable, y apasionada con la familia, la plantación de iglesias y el servicio a la comu...Mostrar másÚltima actualización: hace más de 30 días
Customs and Border Protection Officer - Experienced

Customs and Border Protection Officer - Experienced

U.S. Customs and Border ProtectionVega Baja, PR, United States
Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of high...Mostrar másÚltima actualización: hace más de 30 días
Sr. Cleaning Validation Consultant

Sr. Cleaning Validation Consultant

PharmaLexVega Baja, Puerto Rico, PR
Quick Apply
Cencora PharmaLex is a highly successful and growing consulting company for the Healthcare industry.Cencora PharmaLex offers professional development, training, competitive compensation, plus a sti...Mostrar másÚltima actualización: hace más de 30 días
Handyperson

Handyperson

Mentor Technical GroupVega Baja, PR
Quick Apply
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Mostrar másÚltima actualización: hace más de 30 días
FACULTAD - ADMINISTRACION DE SISTEMAS DE INVERNADERO - CENTRO DE VEGA BAJA

FACULTAD - ADMINISTRACION DE SISTEMAS DE INVERNADERO - CENTRO DE VEGA BAJA

Caribbean UniversityVega Baja, Vega Baja, Puerto Rico
Profesor - Administracin de Sistemas de Invernaderos.Grado Asociado o Bachillerato en área de especialidad con Sistemas de Invernaderos de una Institución acreditada.Experiencia laboral en áre...Mostrar másÚltima actualización: hace 16 días
URGENT : Housekeeper Wanted - Experienced Housekeeper Needed In Vega Baja, Puerto Rico $10.50 / Hour

URGENT : Housekeeper Wanted - Experienced Housekeeper Needed In Vega Baja, Puerto Rico $10.50 / Hour

Housekeeper.comVega Baja, Puerto Rico, USA
Note from Homeowner I am seeking a reliable and detail-oriented housekeeper for my home in Vega Baja, Puerto Rico.The ideal candidate will have experience in maintaining a clean and organized house...Mostrar másÚltima actualización: hace 22 días
CSV Specialist

CSV Specialist

QRC Group, IncVega Baja, Vega Baja, Puerto Rico
CSV Specialist to provide technical support to a pharmaceutical facility with experience in solid and semisolid manufacturing, preferably in dispensing systems, tablets, capsules and granulation of...Mostrar másÚltima actualización: hace 12 días
Child Care Specialist (46785)

Child Care Specialist (46785)

WestCareVega Baja, PR
The person in this position will assist the Children’s Coordinator in the provision of therapeutic childcare service for children from 0 – 3 years old in the daycare. Facilitates play activities acc...Mostrar másÚltima actualización: hace 9 días
Product Tester - Fashion (remote)

Product Tester - Fashion (remote)

Apex Focus GroupVega Baja, Puerto Rico, United States
Get Paid to Test New Fashion Products from Home!.Are you passionate about fashion and love trying new styles? Our company is now recruiting individuals nationwide to participate in Paid Product Tes...Mostrar másÚltima actualización: hace 4 días
Tecnico de Mantenimiento

Tecnico de Mantenimiento

Prime Janitorial ServiceVega Baja, PR, PR
Quick Apply
Prime Janitorial is looking for a Housekeeper to join our team.The Housekeeper will clean, sanitize, and maintain private residences and commercial buildings. The ideal person for this position has ...Mostrar másÚltima actualización: hace más de 30 días
  • Oferta promocionada
Experienced Grill Cook (Full Time)

Experienced Grill Cook (Full Time)

EurestVega Baja, PR, United States
Para aplicar en español, haga clic trabajos.We are hiring immediately for full time .Viatris Vega Baja - Road #689 KM 1.Note : online applications accepted. Days and hours may vary (third shift); mor...Mostrar másÚltima actualización: hace 23 días
Esta oferta de trabajo no está disponible en tu país.
IT CSV System Analyst

IT CSV System Analyst

ViatrisVega Baja, Puerto Rico, USA
Hace 8 días
Descripción del trabajo

Viatris Pharmaceuticals LLC

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via :

Providing high quality trusted medicines regardless of geography or circumstance;

Advancing sustainable operations and innovative solutions to improve patient health; and

Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the IT CSV System Analyst role will make an impact :

Key responsibilities for this role include :

Review, assist and in some cases prepare computer system validation deliverables (documentation, testing, and change controls) for computer systems in accordance with relevant regulatory protocols, such as 21CFR parts 11, 210, and 211, aligned to ITQMS policy requirements. Review implementation deliverables to ensure items will meet regulatory and Viatris Standard Operating Procedure requirements.

Participate in gathering the appropriate level of information needed to complete validation documentation. This will require communicating with the proper business, IT and QA personnel to gain the necessary information as well as acquiring proper review and approval activities. This will also require attending and coordinating meetings to complete validation documentation.

Provide validation guidance to implementation teams on an ongoing basis. Create and champion standards for validation process and deliverables. Create and maintain documentation templates to speed the documentation process.

Assist in maintaining schedules for assigned project tasks and coordinating validation tasks (documentation, testing, training, and change controls) with the project manager and team members. Perform follow up on deliverable related tasks with assigned parties. Ability to plan and schedule validation projects. Respond to team members requests for assistance in creating content for validation (documentation, testing, and change controls). As part of project delivery, drive validation workstreams and identify solutions.

Provide management of validation master files, testing project(s), and TrackWise / CMDB CI's including maintaining appropriate controls, quality standards and consistency as required by management. Prepare for planned regulatory authority audits. Respond to requests for access and questions on validation deliverables. Respond to quality audits from internal and external audit constituencies.

Works independently as the Validation workstream representative to ensure new and / or revised software, equipment, processes and / or procedures are validated in accordance with regulatory standards and company policies and procedures. Must be fully proficient in validation processes in a GMP environment.

Perform Computer System Validation (CSV) functions to meet the goals and objectives of a project. Responsible for development and execution of validation function deliverables to support one (or many) projects to include technical development, validation testing, change management / controls, and documentation (SOP's, validation plans, design specs, protocols, architecture specs, and reports) and training.

Provide project oversight for validation processes and procedures; and implements changes and / or improvements to meet appropriate regulatory requirements, internal policies, and current industry practices. Actively represents Computer System Validation on Project teams globally with respect to the interpretation and application of regulatory requirements concerning validation.

Provide support to the IT and QA organizations and project teams to ensure harmonized and consistent use of CSV standards, templates, and procedures for computer system validation for Enterprise Systems with focus on GMP / regulated systems and technologies.

Identify opportunities for continuous improvement of validation philosophy, practice, and procedure to ensure the highest standards.

Provide support to facilitate Initial Risk Assessment and / or functional risk assessment discussions pertaining to CSV. Ensure proper assessments.

Act as a team mentor to other CSV resources and project team members.

Identify and provide updates for IT CSV Policy and SOPs for Document Management, Change Management, and Testing activity.

Assist project teams with CMDB strategy for application set up in Viatris's ITIL tool.

Collaborate with other North America for CSV learning and help implement global Quality / Validation initiatives

Perform other duties as assigned.

The minimum qualifications for this role are :

Requires exceptional technical writing skills.

Must have the ability to create and facilitate all required computer system validation documentation.

Must possess the ability to have strong control over documentation.

Must have the ability to keep current on FDA regulations.

Must possess the ability to enforce standards set forth by Viatris and the FDA.

Validation Practices (CSV) and Standards (such as GAMP 4 & 5).

Technical skills in Microsoft Office Suites.

IT Systems and Automation knowledge.

Knowledge of Documentum or electronic document management practices, tools and applications.

Knowledge in computerized system testing practices, tools and applications.

Knowledge in change management practices, tools and applications.

EDUCATION / EXPERIENCE

Minimum of a bachelor’s degree in engineering or science and / or

Minimum of 4 years of experience in the pharmaceutical industry (or similar industry in Information Systems, Engineering, Technical Services, Production, or related field.)

Combination of experience and / or education will be taken into consideration.

LICENSES / CERTIFICATIONS

Certificate of Completion Accredited and Approved by CIAPR of Regulatory Compliance - (FDA, GMP & GDP, Pharmaceutical Packaging & Manufacturing Process, Data Integrity, Validation)

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.