| Lead Computer Software Validation Engineer !! Remote Role !! at Remote, Remote, USA |
| Email: [email protected] |
| Lead Computer Software Validation Engineer Location: Remote Role Visa: No H1b/CPT MOI: Skype Must Have: LinkedIn Is Must Our client has a critical need for expertise in computer software validation due to the relocation of equipment from one facility to another. This transition has created demands for validation of the Quality Management System (QMS) and Product Lifecycle Management (PLM) software integrated within the ERP system, as well as for the integration of labeling software. The company needs a skilled contractor to ensure that these systems are validated efficiently and effectively, maintaining compliance with industry standards and regulations. Additionally, the contractor will help facilitate smooth project execution by managing other contractors and interfacing closely with the Project Management Office (PMO). Key Responsibilities: Lead Validation Efforts : Spearhead the validation process for the QMS and PLM systems, ensuring compliance with industry regulations and company standards. Develop Validation Strategies : Create comprehensive validation plans, protocols, and reports that align with best practices and regulatory requirements. Oversee Software Integration : Manage the integration of labeling software, ensuring seamless functionality and adherence to compliance standards. Team Leadership : Coordinate and lead the activities of other contractors, providing guidance and support to ensure project success. Collaborate with PMO : Interface heavily with the PMO to provide regular updates, address project challenges, and align on objectives. Conduct Risk Assessments : Identify potential risks in validation processes and propose effective mitigation strategies. Documentation and Compliance : Ensure thorough documentation of all validation activities in line with regulatory guidelines and internal policies. Qualifications: 7+ years of experience in software validation within the Pharma/Med Device space, specifically with QMS and PLM systems. In-depth knowledge of validation methodologies and relevant regulatory frameworks (FDA, ISO). Experience with ERP systems and software integration, particularly in labeling processes. Flexibility to travel as project demands require. Thanks & Regards .! Manish Chaubey Technical Recruiter | Adventa Tech Inc (An E- VERIFIED COMPANY) 24916 Earls Ford Drive Chantilly, VA 20152 Email : [email protected] Hangout : '[email protected]' https://www.linkedin.com/in/manish-choubey-9939b8238/ Disclaimer : This communication, along with any documents, files or attachments, is intended only for the use of the addressee and may contain confidential information. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of any information contained in or attached to this communication is strictly prohibited, To remove your email address permanently from future mailings, please send REMOVE to [email protected] -- Keywords: information technology Virginia Lead Computer Software Validation Engineer !! Remote Role !! [email protected] |
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| Sat Nov 09 02:36:00 UTC 2024 |