Csv Specialist

Puerto Rico
Permanente
Tiempo completo

Hace 5 días

Company DescriptionQRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.Log on now to our website / to learn more about our services and solutions!Job DescriptionCSV Specialist to work projects like Plant Information System Upgrade, Non Sterile Area integration to PI, Decommissioning of a temperature monitor sensor (System and Software), among others.Duties will include:Develop Change Control records, as required, following site Electronic Change Control (e-CC) Procedure.
Perform Computerized System Validation (CSV) activities following site CSV Standard Procedure.
Communicate to site leaders the tasks progress and roadblocks, or any requirements not met by the project.
Collaborate with other department members to review/update documentation related to the projects assigned.
Develop the testing protocols in their system and/or any other required documentation procedures.
Coordinate meetings with technical or other multidisciplinary teams to develop and revise required documents.Experience and knowledge:Change Controls Management
CSV Risk assessment\
Validation Plan
Data Integrity/Data Mapping
Factory Acceptance Test
User Requirements Specifications (URS)
System Specifications (Design and/or functional specifications)
Configuration Specifications
Data migration (if applicable)
Traceability Matrix
OQ and IQ Protocol
Security and Disaster Recovery
Cybersecurity Assessments
Documentation systemQualificationsBachelor's Degree in Engineering, Computer Systems or related disciplines combined with at least five (5) years of CSV and Change Control Management working experience or a
Master's Degree in Engineering, Computer System or related disciplines combined with at least one (1) year of CSV and Change Control Management working experience.
Experience must be within a Pharmaceutical / Biotechnology Environment working in the development of CSV assessments and testing protocols and developing and managing Change Control Records.
Capable of reading and interpreting drawings and designing specifications and any other technical document.
Knowledge in Plant Information (PI) System, ColdStream and TempTale Systems is preferred.
Capable of understanding and using computers and software packages.
Knowledge of cGMP's, local/federal regulatory requirements and documentation procedures pertaining to pharmaceutical manufacturing plant.
Bilingual English/Spanish, both written and verbal are required.
Able to interact effectively with people to establish and maintain excellent working relationships with internal and external customers at all organizational levels and disciplines in such a way to facilitate the work.
Able to plan and prioritize multiple activities simultaneously.
Effective written and oral communication skills.
Customer service oriented and self-starter.
Ability to exercise good judgment.Additional InformationAll your information will be kept confidential according to EEO guidelines.

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