We are urgently hiring for the position of 'Manager IT - Business applications (Regulatory Software)' with a leading Pharmaceutical based at Mumbai.
Please refer below for the role below :
- Primarily focusing on pharma regulatory submission processes and software.
- Responsible for implementation of projects & Applications like:
- RIMS (Regulatory Information Management Systems).
- Drug Risk and Safety software
- AMS (Artwork Management System)
- Standardize and harmonize application across all geography
- Work with Business Process Owners to firm up the business requirements and develop solution architecture.
- Assist the business users with the functionality, and participate in the blueprinting of business processes and system integration challenges.
- Design, Project implementation, Enhancement responsibilities for applications.
- Leverage existing applications, systems and processes.
- Setup application & interface standard, guideline and checklist for various teams.
- Ensure user base is effectively trained and positioned to use all available system functionalities.
- Ensure IT activities are executed according to regulatory compliance standards. Work with Corporate QA to ensure compliance requirements are met.
- Manage the vendors / partners / support teams; coordinate with Lupin's Subject Matter Experts (SMEs) and location IT team.
Functional Expertise :
- 5 + years of experience in delivering regulatory software and ability to architect solutions, preferably Pharma domain.
- Knowledge of Regulatory submission process and Manufacturing processes in Pharma industry.
- Knowledge of GXP validated environment is must.
- Knowledge of software validation practices
Soft-skills required
- Good verbal and written communication skills required
- Good interpersonal skills; good team player with ability to build relationships.
- Good analytical skills and detail orientation.
If Suitable: Please revert with your updated CV and following details
Current CTC (Fixed CTC + Variable) :
Expected CTC :
Current Location :
Home Town :
Marital Status :
Notice Period :
Neha Shukla | Senior Consultant | Spectrum Talent Management | (ISO Certified 9001:2008) |
C-142 Sector 63 | Noida - UP | India |
Tel: +91 120 338 4931
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