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2 months ago
Werum PAS-X MES Service Delivery Manager/Offshore Lead/Project Manager
Technical/Functional Skills
Werum PAS-X
Key Responsibilities
- Oversee the end-to-end MES service delivery lifecycle, including planning, implementation, operation, and continuous improvement.
- Develop and implement service delivery strategies and processes aligned with business objectives and regulatory compliance.
- Monitor and manage key performance indicators (KPIs) to measure service delivery effectiveness and compliance adherence.
- Ensure adherence to SLAs, SLOs, and regulatory requirements.
- Manage service requests, incidents, and problems while maintaining compliance.
- Coordinate with IT infrastructure, quality assurance, and regulatory affairs teams.
- Build and lead a high-performing MES service delivery team.
- Provide coaching, mentoring, and development opportunities for team members.
- Foster a culture of compliance, quality, and continuous improvement within the team
- Build strong relationships with the customers.
- Understand customer needs and requirements in the context of life sciences regulations.
- Manage customer expectations and resolve issues promptly while maintaining compliance.
- Proactively identify and address customer pain points and regulatory challenges.
- Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements for the new MBR
- Troubleshoot and defects resolution during validation of Master Batch Records
- Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch Records
Experience Required
- Design and creation of complex MBR for Weighing & Dispensing, Manufacturing and Packaging processes
- Site specific requirement analysis for each of the above processes and convert them into Batch Records
- Validation of the created MBRs for site deployment
- Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR’s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data
- Designing and developing State Diagrams in MES
- Determining updates for Master Data, State Diagrams, Equipment management
- Experience on SAP-MES interface, L2 integrations, report development
- Knowledge of ISA95/S88 standards & practical use of these standards in application design, Knowledge of Pharma manufacturing.
- Good Communication and Analytical skills
- Hands on Experience in Werum PAS-X Specification, Execution, Compliance & Performance Module
- Experience in Werum PAS-X - Configuration, Customization
- Experience on Werum PAS-X Installation, Upgrade, Development and Configuration.
- Knowledge of GxP, GAMP, 21 CFR Part 11