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Production Machine Operator- Active Pharmaceutical Ingredient (API)/ Bulk Drug

NQR Code:2022/LS/LSSSDC/06855

  • Old Code: 2022/LS/LSSSDC/06855

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About this Qualification

Job Description

The production machine operator is responsible for operating the machines following Good Manufacturing Practices for the manufacturing/packaging of bulk drugs / active pharmaceutical ingredients (API). The job holder performs basic in-process quality checks to verify that the quality parameters are met for batch manufacturing/ continuous manufacturing. He/ She also generates the critical records for every activity performed in compliance with data integrity rules.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Diploma In any field No Experience None
Previous NSQF qualification of Level 3 2 years None
12th Completed No Experience None
2 year Diploma after 12th In relevant field No Experience None

Progression Pathway

  • Vertical progression
  • 1. Production Supervisor/ Junior Chemist – API/Chemical Manufacturing/ Packaging
  • 2. Production Chemist- Life Sciences (API/ Non Sterile Formulation/ Sterile Formulation/ AYUSH/ Sanitary Products)
  • Lateral/Horizontal progression
  • 1. Production Machine Operator- Non Sterile Formulation (Level- 4)
  • 2. Production Machine Operator - Sterile Formulations (Level-4)
  • 3. Production Machine Operator- AYUSH Products (Level-4)

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Compulsory Bridge Module: Introduction to life sciences industry and applicable regulations & Fundamentals of Manufacturing in Life Sciences Sector N/A Mandatory 30 1.00 4
Perform pre- production check and prepare machines for bulk drug production LFS/N0213, v4 Mandatory 90 3.00 4
Adherence to Environment, health and safety guidelines in a production facility and GMP controlled areas LFS/N0112, v2 Mandatory 30 1.00 4
Maintain compliance with Good Manufacturing Practices (GMP) and other regulations LFS/N0265, v2 Mandatory 120 4.00 4
Ensure a hygienic and clean work area to avoid contamination LFS/N0113, v2 Mandatory 30 1.00 4
Coordinate and communicate with Supervisor/ production chemist, teams and auditors LFS/N0104, v3 Mandatory 30 1.00 4
Employability Skills DGT/VSQ/N0102, v1 Mandatory 60 2.00 4
Elective 1 : Non-Sterile Manufacturing : Perform non- sterile bulk drug/API manufacturing operations LFS/N0214, v4 Elective 90 3.00 4
Elective 2: Non-Sterile Packaging : Perform primary packaging operations for Bulk Drug / API LFS/N0266, v2 Elective 90 3.00 4
Elective 3 : Sterile Manufacturing and Packaging : Perform sterile Bulk drug API/ manufacturing and primary packaging operations LFS/N0267, v2 Elective 90 3.00 4