Job description

Job Summary

Hands on experience in MES Validation and understanding of GXP and 21 CFR Part 11 concepts.

Expertise in writing & executing IQ OQ & PQ scripts.

Good knowledge on Testing methodology & testing validated systems. Understanding of defect management lifecycle process.

Knowledge on Good Documentation practices in Life science/Pharma domain.

Excellent written and verbal communication Skills.

Hands on experience in IT processes in manufacturing and in validating manufacturing

Roles & Responsibilities

Understand the paper Batch record and business process flow in collaboration with business SMEs

Perform functional verification of the modelling and workflows.

Creating/updating test scripts for integration and end to end testing (including interfaces with SAP and automation layer)

Author Computer System Validation (CSV) documents such as Functional Risk Assessment Validation Plan System Test Plan Test Summary Reports (IQ/OQ/UAT) Validation Report etc. following industry standard GAMS 5 and/or following the B. Braun Quality standards. Create test scripts (IQ OQ PQ)

Perform IQ (application and devices) OQ (including the Siemens CAMSTAR / OpCenter MES System integration with SAP PAC and other L3/L2 systems) Development and Prod environment and perform PQ

Defects recording and communication to development team during the testing phase (IQ/OQ/PQ) get them fixed and retest if required

Assist Recipe Author / Modeler in Key user and end user training content creation based on the standard Siemens CAMSTAR / OpCenter MES System product training material

Assist CoE and Site in conducting End user training

Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Apr 05 2023

About Cognizant Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @USJobsCognizant.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
If you have a disability that requires a reasonable accommodation to search for a job opening or submit an application, please email CareersNA2@cognizant.com with your request and contact information.

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