Responsibilities: Process Engineer/Validation Engineer having strong background in statistics, process monitoring and advanced statistical data analysis. Strong background in statistics, process monitoring and advanced statistical data ...
Responsibilities: Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making. ...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Job Description Expert in CSA validation principles. Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. Developing, reviewing, and executing testing documentation. Direct experience a...
Responsibilities: Lead the management of CDM deliverables in coordination with internal and external cross-functional teams. Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high qual...
Responsibilities: Work closely with operations and the business functions to ensure quality performance of products and processes. Initiation and ownership of NC and CAPA, builds proficiency in problem-solving and root-causing activities...
Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). If applicable, develops and provides department training for applications and standa...
Responsibilities: To spearhead the architecture, design, and development (through a high-performing team) of innovative solutions for product project and sustenance delivery, ensuring alignment with strategic objectives. To ensure knowle...
Responsibilities: Strong programming skills in SAS / R programming and data analysis. Extensive work experience with large US insurance claims databases, electronic medical records, registry databases for health outcomes research (e.g., ...
Responsibilities : Strong programming skills in SAS / R programming and data analysis. Extensive work experience with large US insurance claims databases, electronic medical records, registry databases for health outcomes research (e.g.,...
Responsibilities and Requirements: Automation Inventory Analysis- RPA Project Support CSV In addition to validation and regulation experience, the resource should have the following experience: Be familiar with CSV, especially requiremen...
Responsibilities: Conducts literature & landscape reviews to identify concepts of importance to patients to develop disease conceptual models. Identifies & evaluates existing COA tools to determine the extent to which the assessments are...
Responsibilities: Perform tasks identified as part of the overall project plan including, but not limited to Planning, development, and implementation of analytical TMV-related documentation such as validation plans, validation protocols...
Responsibilities and Requirements: Resource should be an expert in validation and compliance of Pharma processes, active involvement in qualification and documentation of applications and tools. Skills Required: Quality Assurance, Compl...
Responsibilities: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and anal...
Responsibilities: Ability to read Process & Instrumentation Drawings is a plus. Ability to read electrical diagrams. Ability to read logic diagrams. Ability to diagram using CAD software. Low-voltage electrical design & layout a plus....
Responsibilities: Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data M...
Responsibilities: Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for ...
Specific Job Responsibilities Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufactur...
Job Description The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin b...