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Assistant Manager Aqa

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 positioning itself as a Contract Development & Manufacturing Organization (CDMO), aiming to provide integrated solutions for:

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

The organization combines:

  • Flexible manufacturing capacity
  • Advanced equipment systems
  • Agile and collaborative workflows

This enables efficient scaling of biologic products—from pilot batches to clinical quantities—helping accelerate time-to-market.

Core Functional Areas

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

  • Quality
  • Precision
  • Successful development of biologics, biotherapeutics, and biosimilars

Job Details / Key Responsibilities

1. Documentation & Record Review

  • Review test records and electronic audit trail logbooks
  • Evaluate:
    • Method development
    • Method validation
    • Stability test records and reports

2. Quality Assurance (QA) Documentation

  • Review records from:
    • Analytical Development Laboratory
    • Quality Control Laboratory
  • Ensure:
    • Proper QA documentation practices
    • Online documentation compliance
    • Reporting of deviations through QMS

3. Procedure Management

  • Ensure:
    • Issuance of approved procedures
    • Availability to ADL & QC teams
    • Strict adherence to procedures

4. Quality Management System (QMS) Compliance

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

5. GMP & GLP Compliance Monitoring

  • Verify compliance with:
    • Good Manufacturing Practices (GMP)
    • Good Laboratory Practices (GLP)
  • Ensure:
    • Proper facility maintenance
    • Controlled environmental conditions
    • Material segregation
    • Correct status labelling
  • Handle deviations through QMS processes

6. Investigation Support

  • Assist supervisors in investigations related to:
    • Complaints
    • Batch failures
    • OOS (Out-of-Specification) / OOT (Out-of-Trend) results
    • 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 monitoring

8. Audit Support

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

9. Audit Follow-up & Closure

  • Coordinate with departments for audit responses
  • Track:
    • Action items
    • Timely closure of audit observations