Adit************

CSV (GxP), QMS, Validations, Qualifications, Risk Assessments, GLP & GMP Documentation Specialist

  • 173205 Baddi India 
  • Graduation: Bachelor of Pharmacy, PG Diploma in Protein Modelling and Rational Drug Design

  • Hourly / Daily / Monthly Rates: N/A

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

  • Last Update: 25.08.2020 at 02:04

Job Type
Freelancer/ Contract
Availability
Available
Place
Baddi
Country
India

Skills

Technical Skills
 Quality Management System (QMS)
 Validation and Qualification (Process, Cleaning, Equipment, System & Facility)
 Computerized system (GxP) Validation
 Risk Assessments
 Investigations & Compliance
 Good Documentation
 Team Management
 Employee training
 Auditing
 Project organization
 Problem resolution
Instrumentation Skills
 Instrumentation (HPLC, UV-Visible Spectrophotometer, Dissolution Apparatus, Disintegration Apparatus, Friabilator)
Computational Skills
 Specialized in Accelrys Software’s Cerius2, Insight-II and Catalyst
 Familiar with Windows and Linux platforms
 Statistical and Analytical Systems (SAS)
 Office Automation: MS-Office and Internet Browsing.


Refrences

1) Professional Project Experience:                                                                                                                                                          1.1) Computerized System (GxP) Validation (Jun 2015 - Feb 2016)
        Marksans Pharma Ltd., Goa – India.
        Carried out Computerized System Validation for GxP systems such as 6 HPLC, 1 GC, 1 Server.                                                                  1.2) Document Management System (DMS)Validation (Oct 2015 - Feb 2016)
         Marksans Pharma Ltd., Goa – India.
         Carried out Computerized System Validation for GxP systems such as Document Management System (DMS) and it’s Server.
1.3) Computerized System (GxP) Validation (Jun 2019 - Nov 2019)
       Curetech Skincare, Baddi – India.
       Carried out Computerized System Validation for GxP systems such as 5 HPLC, 1 GC, 1 UV-VISIBLE Spectrophotometer, 1 FTIR.

2) CSV Consultant (Jun 2019 - Nov 2019)                                                                                                                                                                Curetech Skincare, Baddi – India.
    Carried out Computerized System Validation for GxP systems such as 5 HPLC, 1 GC, 1 UV-VISIBLE Spectrophotometer, 1 FTIR.

3) QMS Consultant (Jun 2019 - Nov 2019) Curetech Skincare, Baddi – India.

4) Audit


Time and Spatial Flexiblity

India. Can be relocated based on type of project

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