| Open Roles - 8/23/2024 at Remote, Remote, USA |
| Email: [email protected] |
| Do not work on any previous roles, these are the open positions at the moment. Will keep you posted about the previous subs Title: SAP PLM Consultant 12 months Foster City, CA Hybrid Client: Pharma $50hr c2c max okay with H1 ( Look for local Cali or candidates from nearby States Not accepting far off East Coast based candidates ) Must have specification management experience Must come from SAP or Oracle background Must have Pharma manufacturing or healthcare or Clinical or Lifescience Industry domain experience Not looking for more than 4 years of experience Overall 3-4 years of experience in PLM process definition, analysis, design and implementation. Experience with SAP PLM. Provide day to day support to clients on handling service requests Troubleshoot and provide resolution to the issues reported by users, integration issues reported / Identified Knowledge of Agile SDK, PX, Events, WSX, ACS, Agile Import/Export, data loads, ACP. Knowledge of Distributed files management and Auto Vue in Agile PLM. Extensive experience with configuration and testing SAP modules Have worked on integrations for items master or bills of material from PLM to EBS or SAP. Title: Validation Analyst with Regulation Raleigh, NC Hybrid Pharma 60hr c2c max USC/GC Not looking for more than 6 years overall experience Should have bachelors from the US Mandatory skills: Validation Analyst Medical device computer systems validation SaaS, compliance, FDA requirements Risk assessment, testing, documentation Subject matter experts, 21 CFR Part 11 requirements Description: Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11. Excellent knowledge of computer system validation and GAMP -5 standards. The client is looking for the below: Responsible for following ADC quality system procedures for non-product computer systems validation, primarily SaaS validation. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Looking for significant experience in medical device computer systems validation. Including project management, risk assessment, requirements definition, testing and all documentation. Identifying and working with / taking directions from system owners, subject matter experts, and quality approvers. Must have significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements. Must have experience with validation of 21 CFR Part 11 requirements. Data Analyst with Regulatory and Veeva Vault Hybrid at Foster City, CA Client: Pharma $55hr c2c USC/GC only Should have Bachelors from the US - Bachelor s degree in regulatory affairs, life sciences, data science, or a related field; advanced degree preferred. Should have overall and under 5 years of experience Should have 10/10 communication Should have bachelors from the US We are seeking an experienced Regulatory Affairs Specialist with a strong background in data analysis, Veeva Vault, Regulatory Information Management (RIM), ERP systems, and business process optimization. The ideal candidate will support regulatory compliance, streamline business processes, and manage regulatory data within the pharmaceutical or life sciences industry. Conduct data analysis and reporting in support of regulatory requirements. Identify and recommend analysis of data quality or integrity issues. Evaluate data quality metrics and data quality audits to benchmark the state of data quality Adhere to data governance standards and procedures. Proven experience in regulatory affairs, with a strong focus on data analysis and process optimization. Extensive experience with Veeva Vault, particularly in RIM applications. Knowledge of ERP systems and their integration with regulatory processes. Strong analytical skills with proficiency in data analysis tools (e.g., Excel, SQL, Tableau, Power BI). Excellent understanding of regulatory requirements, GxP standards, and industry best practices. Implement and optimize Veeva Vault and RIM systems to ensure efficient regulatory information management. Conduct regular audits and data validations to maintain data integrity and accuracy within Veeva systems. Provide training and support to regulatory affairs teams on Veeva Vault and RIM applications. Ensure all regulatory documentation complies with GxP (Good Practice) regulations and industry standards. Develop and maintain process documentation, including standard operating procedures (SOPs), workflows, and user manuals. Assist in regulatory audits and inspections, providing necessary documentation and reports. Thanks, Ashley 228 Irby Lane, Irving, TX 75062 Change/Remove SubscriptionPowered by Zoniac Siliconstar Tech, 228 Irby Lane, Irving, Texas 75062 Phone: 972 256 8154 Keywords: business intelligence green card California North Carolina Texas Open Roles - 8/23/2024 [email protected] |
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| Fri Aug 23 19:45:00 UTC 2024 |