PAS-X Label Design Consultant

Job Title : PAS-X Label Design Consultant. Job Type : Remote. Experience : 8Years. Job Description : We are looking for an experienced PAS-X Label Design Consultant to support the development and implementation of label design processes within our PAS-X (Manufacturing Execution System) platform. The ideal candidate will be responsible for designing, configuring, and maintaining label templates for production processes, ensuring compliance with industry standards and regulations. You will work closely with cross-functional teams, including IT, production, and regulatory compliance, to optimize the label creation process. Key Responsibilities : - Design and Configuration : Create and configure label designs within PAS-X according to the specifications from production, regulatory, and quality assurance teams. - Label Template Management : Develop and maintain label templates for different packaging formats, ensuring they comply with industry regulations (e.g, FDA, GMP, ISO standards). - Integration : Collaborate with other systems (e.g, ERP, LIMS) to integrate label data seamlessly into PAS-X and other enterprise platforms. - Regulatory Compliance : Ensure that all labels are designed and produced in accordance with regulatory requirements such as 21 CFR Part 11, GxP, and other applicable standards. - Troubleshooting and Support : Provide ongoing support for label-related issues in PAS-X, troubleshooting any problems related to label generation, formatting, or data accuracy. - Validation : Work with validation teams to ensure that the label design process is validated as part of system validation procedures. Ensure compliance with validation protocols (IQ/OQ/PQ). - Collaboration : Coordinate with the manufacturing and packaging teams to understand label requirements, ensuring the labels meet operational and regulatory needs. - Process Improvement : Continuously evaluate the label design and generation processes within PAS-X, identifying areas for improvement to enhance efficiency and compliance. - Training and Documentation : Provide training and guidance to internal teams on label design processes and PAS-X functionality. Maintain clear and up-to-date documentation for all label templates and related procedures. - Audit Support : Assist in audits and inspections by providing relevant label design documentation and addressing any findings related to labeling practices. Required Skills & Qualifications : - Bachelor's degree in Engineering, Information Technology, Life Sciences, or a related field. - Proven experience in PAS-X (or similar MES systems) label design and configuration. - Solid understanding of regulatory requirements for labeling in pharmaceutical, biotechnology, or other regulated industries (e.g, FDA, EMA, GMP, ISO). - Experience in developing and maintaining label templates, including data management and formatting. - Familiarity with barcode generation, variable data printing, and integration with label printing systems. - Strong analytical skills with the ability to troubleshoot complex label-related issues. - Excellent communication and collaboration skills to work effectively with internal teams and stakeholders. - Experience with validation processes in regulated environments, including familiarity with IQ/OQ/PQ documentation. - Proficiency in Microsoft Office (Word, Excel, etc.), and experience with label design software tools. Preferred Qualifications : - Experience in label design within a pharmaceutical or medical device environment. - Knowledge of automated label printing systems and integration with PAS-X or similar systems. - Familiarity with electronic signatures and compliance regulations for labeling (e.g, 21 CFR Part 11). - Certification or training related to PAS-X or other manufacturing execution systems. Work Environment : - Collaborative, dynamic team environment with cross-departmental collaboration. - Ability to handle multiple tasks and deadlines efficiently. - Some travel may be required for system implementation, training, or audits. (ref:hirist.tech)

Location: in, IN

Posted Date: 5/10/2025