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Assistant Manager - Ipqa

Lambda Therapeutic Research
Lambda Therapeutic Research
7 years
1000000 - 1500000
Ahmedabad, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Organisational Overview

Company Name: Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Ltd. is establishing itself as a Contract Development & Manufacturing Organization (CDMO) with a vision to provide integrated solutions for:

  • Biologics drug development
  • GMP manufacturing
  • First-in-Human (FIH) clinical trials at a global level

The organization leverages:

  • Flexible production capacity
  • Advanced equipment systems
  • Agile and collaborative processes

This enables efficient scaling of biologic products from pilot batches to clinical-scale production, accelerating time-to-market.

Integrated Capabilities

The company offers end-to-end support through advanced technical functions to:

  • Strengthen development pathways for biologics and biosimilars
  • Ensure quality, precision, and successful outcomes

Job Details / Key Responsibilities

1. Batch Record Review & Documentation

  • Review:
    • Batch records
    • Logbooks
    • Batch record review sheets
  • Fill and verify:
    • Line clearance formats
    • Sampling formats
    • Other applicable documentation

2. Quality Assurance (QA) Documentation

  • Review records from:
    • Warehouse
    • Production
    • Engineering teams
  • Ensure:
    • Accurate QA documentation
    • Online documentation compliance
    • Reporting of deviations via incident reporting system

3. Procedure Control

  • Ensure:
    • Issuance of approved procedures
    • Availability to manufacturing team
    • Strict adherence to SOPs

4. QMS Compliance Monitoring

  • Monitor adherence to Quality Management System (QMS) elements:
    • Change Control
    • Incident Management
    • CAPA (Corrective and Preventive Actions)
  • Conduct checks on the shop floor

5. GMP Compliance & Facility Monitoring

  • Ensure compliance with Good Manufacturing Practices (GMP):
    • Facility maintenance
    • Environmental conditions
    • Material segregation
    • Status labeling
  • Handle deviations through QMS procedures

6. Investigation Support

  • Assist in investigations related to:
    • Complaints
    • Batch failures
    • OOS (Out-of-Specification) / OOT (Out-of-Trend)
    • Incidents
  • Responsibilities include:
    • Data collection
    • Conducting interviews

7. Root Cause Analysis & CAPA Management

  • Coordinate with cross-functional teams
  • Perform:
    • Root cause analysis
    • CAPA documentation
  • Ensure:
    • Timely implementation
    • Effectiveness tracking

8. Audit Support

  • Assist in:
    • Internal audits
    • External audits
  • Responsibilities:
    • Provide documents and clarifications
    • Maintain audit records
    • Follow supervisor instructions

9. Audit Follow-up & Closure

  • Coordinate with departments for audit responses
  • Track and ensure:
    • Closure of audit observations
    • Completion of action items within timelines