COMPUTER SYSTEM VALIDATION CSV jobs in USA, United Kingdom #7

assessments conducted. Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk... working knowledge of computer system validation/computer software assurance requirements. Knowledge of infrastructure...

, Compliance, Records Management, Data Integrity, and / or Computer System Validation (CSV). Experience must include proven...

applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA... and improvements. Collaborates with Computer System Validation (CSV) in authoring and execution of validation test scripts. Develops...

and priorities for the QC Laboratory. Support as CSQA/CSV SME and approver for QCL (Quality Control Labs) computer systems...-conformance investigations, change control proposals, procedure revisions, qualification and validation lifecycle activities...

with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles.... Manual and automated system test method development and qualification. Represent Validation Engineering when collaborating...

with designated personnel to develop various Computer Systems Validation (CSV) documents per FDA guidance (General Principles.... Manual and automated system test method development and qualification. Represent Validation Engineering when collaborating...

assessments conducted. Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk... of computer system validation/computer software assurance requirements Experience with IT Infrastructure, AD, VMware, AWS, Change...

function. The Role Enforce Computerized System Validation (CSV) guidelines, policies, and procedures for control systems... relevant experience will be considered. Pharmaceutical and/or life sciences experience including Computer System Validation...

and retention, and computer system validation Support other core PAT activities (e.g. new equipment installation, system upgrades... deployment of MES-compatible PAT equipment with a focus on computer systems, data integrity, and systems integration Comfortable...

system validation/computer software assurance requirements Knowledge of infrastructure qualification or validation... industry with GMP experience Understanding of Validation Life Cycle approach and practical working knowledge of computer...

Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities... a thorough understanding of computer systems deployed at Devens CTF. Act as CSV Subject Matter Expert (SME) for computerized...

with IS Quality to receive their direction on the Computer System Validation (CSV) program at Aptar. CSVs would be the responsibility... for IT maintenance periods Education BA degree in Computer Science / Software Engineering / or similar required ITIL...

required verification and validation efforts are performed per the assessments conducted Facilitate the computer system validation risk... approach and practical working knowledge of computer system validation/computer software assurance requirements Knowledge...

CSV (computer system validation) and related FDA regulations for computerized systems. Experience managing IT suppliers...

2+ years experience in GMPs and computer systems validation (CSV) Experience with vendor management, including... - Global Serialization Program) is accountable for the delivery of the serialization system in new secondary packaging lines...

. This individual will review and approve system life cycle deliverables (SDLC) and activities to ensure that regulations, protocols... validation activities, including foundational and executable regulatory expectations for CS. The Sr. Associate I, IT Quality...

for quality oversight of computer systems validation (CSV) activities. Key Responsibilities Review and approve computer... and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems...