Hiring || Corporate Quality IT Lead

Job Purpose:

To ensure the entire lifecycle of Computerized Systems (Manufacturing,

Engineering, and Quality) remains in a validated state

• To implement systems and policies for software and electronic data

management across all locations.

• To maintain data integrity compliance through Quality IT surveillance.

Role & responsibilities

• Review of Validation, implementation and changes done in Computerized Systems are in Manufacturing Engineering and Quality, till retirement stage to ensure that the systems are in the validated state throughout its life cycle.
• Implementation of systems and policies governing software and electronic data management across locations
• Quality IT surveillance of the Quality IT system to ensure data integrity compliance.
• Organize training for review of software electronic data from Quality aspect such as review of Raw data and Meta data, verifying whether User management and IT controls are in line with the respective SOP etc. Scheduling/conducting the training program and evaluating effectiveness of trainings.
• Monitor and guide the sites for validation of computerized system validation with respect to Compliance Assessment of Legacy systems, Periodic review, Post implementation review and training on Computerized System Validation as per the requirement (Quality and Operation).
• Support for global IT project implementation
• Collate periodic review reports from sites and propose any action as required and monitor implementation

D. Skills &Capabilities

Core Competencies

• Collaboration; results oriented
• Analytical and critical thinking capabilities
• Leadership , objective setting and performance management
• Strong ethical values and commitment to compliance, integrity

Functional Competencies

• Understanding of Current G.A.M.P Compliance
• Training compliance
• Create a work environment that enables high employee engagement

Experience

• 10-15 years of experience (~ 5 yrs direct IT system QA

Related Experience

• Proven track record of driving transformation in Computer

Systems

Preferred candidate profile

• MSc in Chemistry /M Pharma (Any Computer Related

Course/Degree is Desired)

shikha.mishra@walterbushnell.com