Opportunities
EMR IT is always looking for talented professionals
We are currently recruiting professionals for the below listed job opportunities.
Validation Engineer (contract)
Generates, Reviews, Resolves, and approves Cleaning, Process, and Shipping Validation Master Plans, Writes, reviews and executes a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications, functional requirement specifications, detailed design specifications, factory acceptance test documents, verification protocols, and/or commissioning test procedures, Writes reports to summarize validation/verification /commissioning and/or revalidation/verification/commissioning activities, Generation of reports, deviations or other technical documents, Installation, Operational and Performance Qualification protocol generation and execution, Performs validation/qualification studies to include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation, Conduct risk assessment of existing and new processes/technology/ equipment and manage the impact of potential failure Qualities / Qualifications: MS in Engineering (Biomedical, Bio-Engineering, Biotechnology & Chemical) or equivalent, Must be flexible and adaptable to a fast-paced, rapidly changing environment, Strong interpersonal skills and ability to work in a team environment, Excellent customer service skills, you must be able to interface professionally and appropriately with the client, Excellent written and verbal communication; excellent technical writing skills. Additional Information Equal Opportunity/Affirmative Action employer.
Regulatory Affairs Specialist (contract)
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic area and discipline relevant to assigned projects, Submission activities for device regulatory approvals including CE mark, U.S. premarket approvals (PMAs), U.S. premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, Maintain product technical files for ongoing activities related to compliance with global directives and regulations, Contribute to the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market surveillance activities in support of U.S. FDA and international regulatory submissions, as required, Assist in the regulatory review of labels, labeling, advertising and promotional materials, Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements, Creation of operating procedures and policy guidelines. Qualities / Qualifications: MS in Pharmaceutical Sciences, Molecular Biology, Microbiology, Pharmacy, Regulatory Affairs, related or equivalent, Must be flexible and adaptable to a fast-paced, rapidly changing environment, Strong interpersonal skills and ability to work in a team environment, Excellent customer service skills, you must be able to interface professionally and appropriately with the client, Excellent written and verbal communication; excellent technical writing skills. Additional Information Equal Opportunity/Affirmative Action employer.
Quality Engineer (contract)
Conducting audits to good manufacturing practices, international organization for standardization and any other applicable standards, Providing complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes, Utilizing multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices , equipment engineering system , and international organization for standardization, Addressing and correcting product and process complaints, Reporting on contract manufacturer performance metrics and management reviews, Oversee audits of all quality system categories to assess compliance to process excellence standards, supplier quality activities with a focus on supplier selection, qualification, audits, and supplier corrective actions, Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, and present reports to management, Provide Quality Engineering support to suppliers including inspection technique support, verification/validation activities, CAPA and change management, Ensure that FDA CFR Part 820 and ISO 13485 regulations/standards are understood and followed at suppliers Qualities / Qualifications: MS in Engineering (Mechanical, Industrial, Electrical & Chemical) or equivalent, Must be flexible and adaptable to a fast-paced, rapidly changing environment, Strong interpersonal skills and ability to work in a team environment, Excellent customer service skills, you must be able to interface professionally and appropriately with the client, Excellent written and verbal communication; excellent technical writing skills. Additional Information Equal Opportunity/Affirmative Action employer.
Please email your word formatted resumes at hr@emritsolutions.com