Manager - QA ( QMS, DMS Project ) and QC lab ( Lims, Chromoleon)

SPECTRUM TALENT MANAGEMENT
  • Mumbai
  • 15-20 lakh
  • 6-11 years
  • Views
  • 17 Jul 2019

  • Testing - Software

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Job Description


PositionManager IT


Nos 1


Department IT


Location Mumbai


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. 


Job Specification
Qualification B.E./B.Tech/MCA/B.Pharma
Years of Relevant Experience 6-12 Years
Gender Male/Female

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:
  1. LIMS (Laboratory Information Management System)
  2. CDMS (Chromatography Data Management System)
  3. 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.
Functional Expertise :
  • 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.
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.


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SPECTRUM TALENT MANAGEMENT