Job Title: Assistant Manager – IPQA (In-Process Quality Assurance)
Job Category: Quality Assurance / Manufacturing / GMP Compliance
Job Type: Full-Time
Experience Level: 7+ Years
Location: Ahmedabad, Gujarat, India
Req ID: 1466
CTC Range: INR 10,00,000 – 15,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global Contract Development & Manufacturing Organization (CDMO) focused on biologics drug development, GMP manufacturing, and enabling First-in-Human (FIH) clinical trials. Lambda provides integrated solutions for scaling biologics from pilot batches to clinical quantities, ensuring quality, precision, and compliance across all operations.
Role Overview
Lambda Therapeutic Research is seeking an experienced Assistant Manager – IPQA to oversee in-process quality assurance activities across manufacturing operations. The role will ensure compliance with GMP standards, QMS procedures, and operational excellence within production, warehouse, and engineering functions.
Key Responsibilities
Review batch records, logbooks, line clearance, sampling records, and batch review sheets to ensure accuracy and regulatory compliance.
Monitor documentation maintained by Manufacturing, Warehouse, and Engineering teams, ensuring online documentation and adherence to incident reporting processes.
Ensure issuance, availability, and implementation of approved procedures for manufacturing teams.
Monitor adherence to QMS elements including change control, incident management, and CAPA (Corrective and Preventive Actions) on the shop floor.
Verify compliance of manufacturing facilities with GMP standards, including facility upkeep, environmental conditions, material segregation, and status labeling.
Support investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, and other operational incidents.
Coordinate cross-functional teams to conduct root cause analysis, document CAPA, monitor implementation, and track effectiveness.
Support internal and external audit activities by providing required information, documentation, and clarification to supervisors and auditors.
Track closure of audit observations and follow up with respective departments for timely resolution of action items.
Required Experience
Minimum 7 years of industrial experience in Manufacturing, Quality Control, Quality Assurance, or Engineering & Development within pharmaceutical or biologics environments.
Proven expertise in GMP compliance, QMS adherence, CAPA management, and operational audits.
Educational Qualification
B.Pharm or Post-Graduation in Microbiology, Quality Assurance, Biochemistry, or Biotechnology.
Professionals with extensive experience in in-process quality assurance, GMP manufacturing, and operational compliance are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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