Ramraj Singh

Operation Head/Plant Head/Quality Head

Talent

Dehra DūnMember since June 1, 2026

Manpower Reduction and Proper UtilizationRejection Control and Yield ImprovementsProcess Optimization and AutomationProcess Improvisation & Quality ImprovementProper Machine Utilization with proper PlanningQuality System ImplementationChange ControlsProcess ValidationTechnology TransferOperational Excellence

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About

With a robust track record of system implementation across plant operations and an unwavering commitment to fostering a quality-driven culture, compliance, and customer satisfaction. Approximately 20 years experience in Pharma Industry with Plant Operations with Operational Excellence, QA, QC, RA, R&D with exposure to diverse dosage forms.

Experience

Sr. General Manager Quality at Nitin Lifesciences-A Synokem Company (2025-04 – Present)

Responsible for Operational Excellence & Quality Operation of the Organization.

Handling of all Technical Matters of the Organization.
Operational Excellence and Operational and Capex Control.
New Project Handling and Leading.
First contact point for all customers for all technical matters.
Technical Excellence & Smooth functioning of the plant.
New product designing, assessment, and execution for products on P2P, Loan License and for export market.
Responsible for Quality related activity of the organization.
Implementation of Quality System in the organization.
To make compliances for National & International Regulatory Agencies as per Current Guidelines like EU GMP, WHO & PIC/S.
Organize need base GMP & GLP Training & Training as per requirement.
Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System
Documents Review & approval.

General Manager QA at Uni Medicolabs (2017-11 – Present)

Responsible for Technical & Quality Operation of all three Plants of the Organization, New Product Handling & Customer Dealing.

Handling of all Technical Matters of the Organization.
First contact point for all customers for all technical matters of all three sites.
Technical Excellence & Smooth functioning of the plant.
New product designing, assessment, and execution for products on P2P, Loan License and for export market.
Coordinator for all new product projects.
Manpower Reduction and Proper Utilization.
Rejection Control and Yield Improvements.
Process Optimization and Automation.
Process Improvisation & Quality Improvement.
Proper Machine Utilization with proper Planning.
New business development.
Planning and execution of new and crucial projects.
Responsible for Quality, Regulatory, Technology Transfer and Rnd related activity of all three Units of the organization.
Implementation of Quality System in all three Plants of the organization.
To make compliances for National & International Regulatory Agencies as per Current Guidelines like EU GMP, WHO & PIC/S.
Organize need base GMP & GLP Training & Training as per requirement.
Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System
Documents Review & approval.

Head QA at Rusan Pharma Limited (2015-01 – 2017-11)

Responsible for Technical & Quality Operation of the Plant.

Handling of all Technical Matters of the Organization.
First contact point for all customers for all technical matters of the site.
Technical Excellence & Smooth functioning of the plant.
New product designing, assessment, and execution for products for Domestic and for export market.
Coordinator for all new product projects.
Manpower Reduction and Proper Utilization.
Rejection Control and Yield Improvements.
Process Optimization and Automation.
Process Improvisation & Quality Improvement.
Proper Machine Utilization with proper Planning.

Head QA at Vivimed Labs Limited (2013-09 – 2015-01)

Responsible for QA, QC/RA & Technical & Quality Operation of the Plant.

Handling of all Technical Matters of the Organization.
First contact point for all customers for all technical matters of the Plant.
Technical Excellence & Smooth functioning of the plant.
Manpower Reduction and Proper Utilization.
Rejection Control and Yield Improvements.
Process Optimization and Automation.
Process Improvisation & Quality Improvement.
Proper Machine Utilization with proper Planning.
New product design, assessment and execution for products on P2P, Loan License and for export market.
Coordinator for all new product projects.
To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, D&C Act & ICH.
Preparation & Up-dation of Documentation like SOP, STP, Validation & Qualification Protocols, Specifications Analytical Method Validation & various documents like Site Master File, Validation Master Plan, Quality Manual, Training Manual, Safety Manual & Product List etc.
Setup Quality Management System in compliance with Domestic Requirements.
To confirm and follow basic cGMP Norms in the Plant.
To guide for Implementation of New Technology in Plant as per Current Regulatory Guidelines.
To Provide Guidelines for Up-dation of Facility.
To Conduct Plant Audit and Provide Guidelines for Better Improvement & Implementation of System.
Preparation of Regulatory Audits and to organize Client Visits & Audits.
Artwork Review & Approval.
To assist & Monitor location QA in Compliance of various Audit discrepancies.
Organize need base GMP Training & Training as per requirement.
Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System.
Documents Review & approval.

Asst. Manager Corporate Quality Assurance at Akums Drugs & Pharmaceuticals Ltd. (2009-06 – 2013-08)

Planning and execution of new and crucial projects.
Responsible for Quality, Regulatory, technology transfer and Rnd related activity of the organization.
Implementation of Quality System in Plant.
To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, PICs, MCC, EU, MHRA & ANVISA.
Preparation of Regulatory Audits.
To assist & Monitor location QA in Compliance of various Audit discrepancies.
Organize need base GMP & GLP Training & Training as per requirement.
Handling of Market Complaints, Deviations, CAPA, Change Controls and other Quality Management System.
Handling of all Technical Matters of the Organization.
First contact point for all customers for all technical matters of the Plant.
Technical Excellence & Smooth functioning of the plant.
Manpower Reduction and Proper Utilization.
Rejection Control and Yield Improvements.
Process Optimization and Automation.
Process Improvisation & Quality Improvement.
Proper Machine Utilization with proper Planning.
New product design, assessment and execution for products on P2P, Loan License and for export market.
Coordinator for all new product projects.
To make compliances for National & International Regulatory Agencies as per Current Guidelines like WHO, D&C Act & ICH.
Preparation & Up-dation of Documentation like SOP, STP, Validation & Qualification Protocols, Specifications & various QA related documents like Site Master File, Validation Master Plan, Quality Manual, Training Manual, Safety Manual & Product List etc.
Setup Quality Management System in compliance with Domestic & Overseas requirements in 07 Plants of the Organization.
To guide for Implementation of New Technology in all Plants as per Current Regulatory Guidelines.
To Provide Guidelines for Up-dation of Facility.
To Conduct Plant Audit and Provide Guidelines for Better Improvement & Implementation of System.
Preparation of FDA & Regulatory Audits along with Location QA.
Implementation of Common Quality System in all Seven Plants of the Organization.

Executive Quality Assurance at Shreya Life Sciences (2008-06 – 2009-06)

Organizing Client Visits & Audits.
To assist & Monitor location QA in Compliance of various Audit discrepancies.
Quality System Documents for New Project.
Organize need base GMP Training & Training as per Location requirement at all Plants.
Participation in Technology Transfer activity, Gap Analysis and vendor audits.
To ensure harmonization of Quality System & cGMP adherence in all Plants.
Handling of Market Complaints, Deviations & Change Controls.
Documents Review & approval.
In charge of Oral Liquid & Lozenges Block.
Management of Departmental Documents.
IPQA, Qualification, Validation Activity in Liquid Oral Dosages Form.
Preparation of Master Formula Record (MFR), Batch Manufacturing & Packing Record (BMR & BPR), Qualification Documents & Various Documents required for Quality System Implementation.
Reviewing of BPCR.
Maintenance of Critically Controlled Area and Working System for Quality Production.
Co-ordination with QC, Production, Store, Packing to Produce Safe, Pure and Effective Quality Product.
Preparation of WHO Required Documents.

Executive Quality Assurance at Alembic. Ltd. (2007-04 – 2008-06)

Verification of Batch Sheet, BPCR, Process Validation Protocols & Reports and Product Release.
Process Validation & Qualifications Activity.
Responsible for In-Process checks during, Tablet, Liquid, Capsule Manufacturing & Packing.
Management of Departmental Documents.
Self-Inspection.
Shop Floor Management.
Calibration of In-process Quality Assurance Instruments.
Maintenance of Critically Controlled Area and Working System for Quality Production.
Co-ordination with QC, Production, Store, Packing to Produce Safe, Pure and Effective Quality Product.
Preparing Daily Documents and Various Formats.
Working allocation to the subordinate.
IPQA Coordinator for Internal and External Audits.
SAP related activity.

Trainee QA at Alkem Labs. Ltd (2006-06 – 2007-04)

In-Process checks during DPI, Tablets, Capsules, Dry Syrup Manufacturing and Packing.
Preparations of daily documents.
Calibration of In-process Quality Control Instruments.
Management of Departmental Documents &Annual Product Review.
Management of Control Samples.
Preparation and reviewing of BPCRs. & Process Validation.
Organizing Client Visits & Audits.
To assist & Monitor location QA in Compliance of various Audit discrepancies.
Quality System Documents for New Project.
Organize need base GMP Training & Training as per Location requirement at all Plants.
Participation in Technology Transfer activity, Gap Analysis and vendor audits.
To ensure harmonization of Quality System & cGMP adherence in all Plants.
Handling of Market Complaints, Deviations & Change Controls.
Documents Review & approval.