Moha***********

Computer System Validation & IT Compliance (IT-QA)

  • India 
  • Graduation: M.Pharmacy

  • Hourly / Daily / Monthly Rates: 1000 / hour 300 / daily 90000 / monthly

  • Languages: English(Full Professional) | Hindi(Full Professional)

  • Last Update: 11.07.2019 at 01:15

Job Type
Full Time
Availability
Not Available
Country
India

Category :

Quality Assurance and Business Operations

   

Quality Assurance and Business Operations

   

Keywords :

  

Account Manager

  

Account Manager


Skills

Close to 8 years of blend work experience in the field of Pharmaceutical-Quality Assurance (In an as Plant QA, CQA & ITQA) from a leading firms like, Dr. Reddy’s Lab, Strides Pharma, IKS Healthcare, Recipharm Pharma Services & Himalaya drug, currently working for Dr. Reddy’s Lab, Hyderabad from March 2018 to till date. Lead across-functional teams with diverse technical backgrounds. Well experienced pharmaceutical quality implementations and SME for IT/CSV background to implementing softwares, applications and users training. Innovative professional with proven ability to identify, analyze and solve problems to reduce the implementation time in line with current regulatory requirements.

  • Risk Taking and Risk Management – Met all target/implementation goals by identifying and tracking high-risk areas, by implementing risk mitigation early and contingency plans & training as needed, through proof-of-concept technical and by maintaining constant communication with Management, Users and Program/Project stakeholders.
  • Result Orientation – Turned around key projects and met, exceeded all goals and objectives. Implementing various applications like SAP, LIMS, Trackwise, MES, LES, Track & trace (Serialization), BMS, EMS, DMS and laboratory/manufacturing standalone systems etc. Virtualization Upgrading new Versions & Patches, System / Software validation completed well in advance as per GAMP. Fully compliance for 21 CFR part 11 and EU Annex-11. Demonstrated skill in organizing work-flow from group sessions through implementation in variety of media and capitalizing on primary competencies of technical and validation teams.

Coaching and Mentoring – Most users/members performed “above expectation” and all users/members raised level of their performance


Time and Spatial Flexiblity

Available for below mentioned countries

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