Job Title: Assistant Manager – Analytical Quality Assurance (AQA)
Job Category: Quality Assurance / Analytical Development / GMP Compliance
Job Type: Full-Time
Experience Level: 7+ Years
Location: Ahmedabad, Gujarat, India
Req ID: 1465
CTC Range: INR 10,00,000 – 15,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Contract Development & Manufacturing Organization (CDMO) focused on biologics drug development, GMP manufacturing, and enabling First-in-Human (FIH) clinical trials.
With integrated capabilities in analytical development, quality control, and GMP operations, Lambda supports clients in accelerating biologics and biosimilar development pathways while ensuring compliance, precision, and operational excellence. The organization maintains global standards and scalable solutions from pilot batches to clinical production quantities.
Role Overview
We are seeking an experienced Assistant Manager – Analytical Quality Assurance to lead QA activities for Analytical Development and Quality Control laboratories. This role will oversee documentation review, GMP compliance, deviation management, investigations, and audit support. The position requires strong technical knowledge, operational experience, and expertise in regulatory compliance within biologics manufacturing environments.
Key Responsibilities
Review test records, electronic audit trails, method development and validation reports, stability studies, and QA documentation.
Ensure compliance of Analytical Development and Quality Control laboratory records with Quality Management System (QMS) and GMP requirements.
Monitor adherence to approved procedures, QMS elements including change control, incident management, and CAPA implementation.
Verify laboratory compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards, including facility upkeep, environmental conditions, segregation, and labeling of materials.
Support investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, and other incidents through data collation and root cause analysis.
Coordinate with cross-functional teams to document, implement, and monitor CAPA actions effectively.
Assist or lead internal and external audits, providing documentation, clarifications, and ensuring timely closure of audit observations.
Maintain accurate records of QA activities and support continuous improvement initiatives within the laboratory and manufacturing environment.
Required Experience
Minimum 7 years of industrial experience in Manufacturing, Quality Control, Quality Assurance, or Engineering & Development within pharmaceutical/biologics environments.
Demonstrated expertise in analytical QA, GMP compliance, deviation investigations, and audit readiness.
Strong knowledge of QMS processes, CAPA, GLP/GMP regulations, and documentation standards.
Educational Qualification
B.Pharm, or Post-Graduation in Microbiology, Quality Assurance, Biochemistry, or Biotechnology.
Candidates with extensive experience in analytical quality assurance, GMP compliance, and biologics development are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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