Werum Pas X developer / - Location : - Mumbai / Pune / Bangalore

Werum Pas X developer / Support

Location : - Mumbai / Pune / Bangalore

Exp Required : - 6 to 12 Years

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

Roles & Responsibilities :

Werum PAS-X Service Delivery

Offshore Lead

Client Liasoning

IT Skills

Knowledge on SQL queries, C-Sharp, Java,

User management and system profile creations.

Generic Managerial Skills

Proven experience in MES implementation and support within the life sciences industry.

Deep understanding of MES functionalities and industry best practices.

Strong knowledge of relevant regulations (e.g., FDA, EMA, GxP) and compliance requirements.

Experience in IT service management frameworks (ITIL) is preferred.

Excellent project management and organizational skills.

Strong leadership and interpersonal skills.

Ability to build and maintain relationships with stakeholders, including regulatory agencies.

Strong problem-solving and analytical skills.

Excellent communication and presentation skills