Job Title: Assistant Manager – Analytical Quality Assurance (AQA)
Req ID: 1465
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 1,000,000 – 1,500,000
Organizational Overview:
Lambda Therapeutic Research Ltd. is a global leader in clinical research and contract development, with a vision to serve as an integrated Contract Development & Manufacturing Organization (CDMO) for biologics. Our capabilities span biologics drug development, GMP manufacturing, and enabling First-in-Human (FIH) clinical trials worldwide. With flexible capacity, advanced equipment, and an agile approach, Lambda accelerates the pathway from pilot batches to clinical-scale production, ensuring quality, precision, and regulatory compliance for biologics, biosimilars, and bio-therapeutics.
Position Overview:
We are seeking an experienced Assistant Manager – AQA to oversee analytical quality assurance activities, ensuring compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and the Quality Management System (QMS). This role is critical in maintaining regulatory compliance, supporting audits, and driving continuous improvement in analytical and quality operations.
Key Responsibilities:
Review test records, electronic audit trails, method development and validation documents, and stability test reports.
Oversee documentation maintained by Analytical Development and Quality Control Laboratories, ensuring compliance with QA protocols and online record-keeping in line with QMS requirements.
Ensure issuance, accessibility, and adherence to approved procedures by the Analytical Development and Quality Control Teams.
Monitor adherence to QMS elements, including change control, incident management, and Corrective and Preventive Actions (CAPA) on the shop floor.
Verify compliance with GLP and GMP standards, including facility maintenance, environmental conditions, material segregation, and labelling; manage deviations per QMS.
Support investigations into complaints, batch failures, Out-of-Specification (OOS)/Out-of-Trend (OOT) results, and incidents by data collection, interviews, and root cause analysis.
Document CAPA, monitor implementation timelines, and evaluate effectiveness of corrective actions.
Assist in internal and external audits by providing necessary documentation, information, and clarification; track and close audit action items.
Collaborate with cross-functional teams to drive quality improvement and regulatory compliance initiatives.
Experience Required:
Minimum 7 years of industrial experience in Manufacturing, Quality Control, Quality Assurance, or Analytical/Process Development within pharmaceutical or biologics operations.
Educational Qualification:
B.Pharm. or Post-Graduation in Microbiology, Quality Assurance, Biochemistry, Biotechnology, or related field.
Why Join Lambda Therapeutic Research:
Work with a globally recognized CRO and CDMO with multi-country operations.
Exposure to end-to-end biologics development and analytical quality assurance processes.
Opportunities for leadership growth, cross-functional collaboration, and professional development in a regulated, high-performance environment.
Gujarat :
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