ncvet-help[at]gov[dot]in
Beta Version
+91 11 25788001-11

Specialist- Quality Assurance (Pharma, Biological Products and Medical Devices)

NQR Code:QG-5.5-LS-00998-2023-V1-LSSSDC

  • Old Code: QG-5.5-LS-00998-2023-V1-LSSSDC

    Copy
About this Qualification

Job Description

A Specialist- Quality Assurance (Pharma, Biological Products and Medical Devices) performs physical checks, conducts document verification exercise, ensures compliance to quality management systems and procedures, undertakes risk control assessment, conducts/participates in internal/external audits and also carries out process and equipment validation and in-process sampling, finished product sampling activities.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
PG In relevant field 2 years None
Pursuing 2nd year of 2 year PG-Degree In relevant field No Experience None
4 year UG degree In relevant field 2 years None
Pursuing 2nd year of 2 year PG-Degree In relevant field No Experience None
Previous NSQF qualification of Level 5 1.5 Years None
Previous NSQF qualification of Level 5 1.5 Years None
Previous NSQF qualification of Level 5 1.5 Years None

Progression Pathway

  • Vertical progression
  • 1.Manager- Quality Assurance (Pharma Biological Products & Medical Devices)
  • 2.Quality Assurance Lead Auditor- (Pharma Biological Products & Medical Devices)
  • Lateral/Horizontal progression
  • 1. QC Reviewer/Section In- Charge (Pharma Biological Products & Medical Devices)
  • 2. Specialist- Quality Control Instrumental Analysis (Pharma Biological Products & Medical Devices)

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Introduction to Life Sciences industry and applicable regulations N/A Mandatory 30 1.00 5
Ensure adherence to Environment, health, and safety guidelines in a manufacturing facility and GMP controlled areas LFS/N0125, v1 Mandatory 60 2.00 5
Coordinate with Manager, colleagues, and auditors LFS/N0302, v3 Mandatory 60 2.00 5
Ensure GxP compliance, respond to issues and non-conformance to maintain regulatory standards and procedure LFS/N0348, v1 Mandatory 120 4.00 5.5
Employability Skills DGT/VSQ/N0103 Mandatory 90 3.00 5
Elective 1: Equipment Validation: Monitor Equipment Validation LFS/N0329, v2 Elective 60 2.00 5.5
Elective 1: Equipment Validation: Review documentation for equipment validation LFS/N0349, v1 Elective 60 2.00 5.5
Elective 1: Equipment Validation: Perform Equipment Validation for change control LFS/N0350, v1 Elective 60 2.00 5.5
Elective 2: Process validation: Perform Process validation LFS/N0305, v2 Mandatory 60 2.00 5.5
Elective 2: Process validation: Documentation for process validation LFS/N0351, v1 Mandatory 60 2.00 5.5
Elective 2: Process validation: Perform Process Validation for change control LFS/N0352, v1 Mandatory 60 2.00 5.5
Elective 3: Internal audit: Carry out Internal auditing activities LFS/N0318, v2 Elective 60 2.00 5.5
Elective 3: Internal audit: Carry out Vendor audit related activities and perform other additional activities to track performance LFS/N0317, v2 Elective 60 2.00 5.5
Elective 3: Internal audit: Carry out audit related reporting and documentation to adhere to regulatory and Quality standards. LFS/N0315, v2 Elective 60 2.00 5.5
Elective 4: Quality Management system : Perform various QMS operations. LFS/N0327, v2 Elective 90 3.00 5.5
Elective 4: Quality Management system : Ensure training related activities and suggesting Improvements to Quality Management System LFS/N0328, v2 Elective 90 3.00 5.5
Elective 4: Stability Studies: Perform Stability Studies. LFS/N0309, v2 Elective 90 3.00 5.5
Elective 4: Stability Studies: Carry out reporting and documentation for QC Stability Studies LFS/N0310, v2 Elective 90 3.00 5.5
Option 1: Loan License Audit: Perform Loan License Audit and documentation activities LFS/N0353, v1 Optional 150 5.00 5.5
Option 2: Regulated Business Operations: Establish own enterprise and perform various entrepreneurial activities to run the business operations in Life Sciences Sector LFS/N0120, v2 Optional 30 1.00 6
Option 2: Regulated Business Operations: Maintain the critical business documents as Entrepreneur in Life Sciences Sector LFS/N0121, v2 Optional 30 1.00 6