| CSV Compliance Specialist. at Chicago, Illinois, USA |
| Email: [email protected] |
| From: Vijay Reddy, VSB Tech consulting services [email protected] Reply to: [email protected] Job: CSV Compliance Specialist. Location: Chicago, IL (Onsite) Key Requirements: Capable of validating/ revalidating the GxP Computerized Systems located in QC, laboratory, manufacturing, warehouse, engineering, QA, IT departments. Capable of validating/ revalidating web-based applications, corporate applications, Infrastructure applications. Capable of qualifying/ re-qualifying on-premises IT infrastructure. Capable of qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaS. Capable of defining the validation strategy and qualification strategy for Retrospective and Prospective systems validation. Capable of preparing or reviewing validation plans and reports. Capable of preparing or reviewing validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment. Responsible to participate vendor qualification and review the report. Capable of preparing or reviewing validation deliverables in specification phase Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc. Capable of preparing or reviewing Risk Assessments and Mitigation actions to ensure compliance during and after system validation. Capable of preparing or reviewing validation deliverables in testing phase Protocols and Test Scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Capable of preparing or reviewing validation deliverables in reporting phase Requirement Traceability Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports. Responsible for ensuring computerized systems inventory list. Capable of authoring computerized systems validation SOPs and it templates for execution. Responsible for preparing periodic review schedule for computerized systems. Responsible for performing periodic reviews to ensure system validated state. Capable of providing training to stakeholders on computerized system procedures and its templates. Capable of conducting or participating in internal/ external audits related to Computerized Systems Responsible for ensuring the compliance of computerized systems with reference to regulatory requirements including but not limited to 21 CFR Part 11 and other applicable regulations. Capable of reviewing or executing Change Control tasks, Deviations tasks, CAPA tasks. Capable of facing regulatory audits, customer audits, external audits and other applicable audits. Capable of validating centralized applications and defining rollout strategy. Responsible for keeping updating on regulations (21 CFR Part 11, EU Vol4 Annex 11, etc..) and guidelines (ISPE GAMP5, PIC/s, ICHQ9, etc..) related to computerized systems validation. Responsible for performing Gap Assessment on legacy computerized systems and providing remedial actions to mitigate the gaps. Capable of reviewing the application/ system change management activities (addendum/ revised specifications, addendum qualifications) during operational phase. Responsible for ownership of assigned projects, programs, and support activities, delivering results within agreed-upon timelines. Responsible for monitoring, guiding, and motivating off-site teams to achieve established milestones and key objectives. Should have Proficiency in technical writing and experience with relevant tools like MS Office Suite and Adobe documentation software. Should have excellent communication skills with a strong command of written and spoken English are essential. Keywords: quality analyst information technology microsoft Illinois CSV Compliance Specialist. [email protected] |
| [email protected] View all |
| Tue Apr 16 21:06:00 UTC 2024 |