Assistant Manager – IPQA (In-Process Quality Assurance) | GMP Manufacturing & Quality Systems
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 10,00,000 – 15,00,000 per annum
Employment Type: Full-Time
Job Overview
Lambda Therapeutic Research Ltd. is seeking an experienced Assistant Manager – IPQA to oversee in-process quality assurance activities within a GMP-regulated manufacturing environment. This role is critical in ensuring compliance with Quality Management Systems (QMS), Good Manufacturing Practices (GMP), and regulatory standards across biologics and pharmaceutical production. The ideal candidate will play a key role in batch review, deviation management, audits, and continuous quality improvement initiatives.
Key Responsibilities
In-Process Quality Assurance (IPQA) Oversight
Review batch manufacturing records, logbooks, and associated documentation for accuracy and compliance
Ensure proper completion of line clearance, sampling records, and batch record review sheets
Monitor real-time documentation practices and enforce data integrity standards
Quality Systems & Compliance
Ensure adherence to QMS elements including Change Control, Deviation Management, and CAPA (Corrective and Preventive Actions)
Oversee implementation and compliance with approved SOPs and procedures on the shop floor
Verify that manufacturing operations consistently meet GMP requirements, including facility conditions, material segregation, and status labelling
Deviation Handling & Investigation
Support and lead investigations related to deviations, complaints, batch failures, and OOS/OOT results
Conduct root cause analysis and ensure timely documentation and implementation of CAPA
Monitor effectiveness of CAPA and ensure closure within defined timelines
Cross-Functional Coordination
Collaborate with Production, Warehouse, Engineering, and Quality Control teams to ensure compliance and operational excellence
Facilitate communication between departments to resolve quality issues efficiently
Audit & Inspection Readiness
Support internal and external audits by providing required documentation, data, and clarifications
Track audit observations and ensure timely closure of action items
Maintain audit readiness and compliance with regulatory expectations
Documentation & Reporting
Ensure proper documentation and reporting of QA activities in line with regulatory and company standards
Maintain records related to investigations, audits, and quality system processes
Required Qualifications
Bachelor’s degree in Pharmacy (B.Pharm)
OR
Postgraduate degree in Microbiology, Quality Assurance, Biochemistry, or Biotechnology
Experience Required
Minimum 7 years of industrial experience in pharmaceutical or biologics manufacturing
Proven experience in Quality Assurance, Quality Control, Manufacturing, or Engineering & Development
Strong hands-on experience in IPQA activities, GMP compliance, and QMS processes
Key Skills
In-Process Quality Assurance (IPQA)
GMP Compliance & Regulatory Standards
Quality Management Systems (QMS)
Deviation, OOS/OOT & CAPA Management
Batch Record Review & Documentation
Audit & Inspection Readiness
Root Cause Analysis & Problem-Solving
Cross-Functional Collaboration
Why Join Lambda Therapeutic Research?
Work with a globally expanding CDMO and CRO offering integrated biologics development solutions
Exposure to cutting-edge GMP manufacturing and quality systems
Collaborative and innovation-driven work environment
Strong opportunities for leadership growth and career advancement
About Lambda Therapeutic Research Ltd.
Lambda Therapeutic Research Ltd. is a global Contract Research Organization (CRO) and emerging Contract Development & Manufacturing Organization (CDMO), providing end-to-end solutions for biologics development, GMP manufacturing, and clinical research. With a strong international presence, the company supports pharmaceutical and biotech clients in accelerating product development and commercialization.
How to Apply
Interested candidates can apply through the official company careers portal or submit their updated resume via ThePharmaDaily.com to explore advanced opportunities in pharmaceutical quality assurance and manufacturing.
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