Nature of employment Permanent
Designation : Manager Technical Application
We have planned key Quality application implementation DMX, LIMS and IPQA for all sites.
For doing above application project management for 2-3 sites at a time, this position is required.
Years of Relevant Experience 6-12 Years
Age Range 27-35 Years
Roles & Responsibilities:
- Primary focusing on QA/QC Lab software for capturing laboratory process and equipment.
- Responsible for implementation of projects, Applications like:
- LIMS (Laboratory Information Management System)
- CDMS (Chromatography Data Management System)
- Instrument connected software like UV, IR, Ph meter, HPLC, GC Software
- Standardize and harmonize application across all Laboratories.
- 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.
- Responsible for Design, Project Implementation, Enhancement for QC applications.
- Leverage existing applications, system processes.
- Setup application & interface standard, guideline and checklist for various teams.
- Ensure IT 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 SMEs and location IT Team.
Soft Skills Required:
- 6+ Years of experience in delivering QC software and ability to architect solutions, preferably Pharma domain.
- Knowledge of Quality Control Lab, Regulatory and Manufacturing processes in Pharma industry.
- Knowledge of GXP validated environment.
- Knowledge of Software Validation Practices.
- Good verbal and written communication skills required.
- Good interpersonal skills; good team player with ability to build relationships.
- Good analytical skills and detail orientation.