Assistant Manager – IPQA
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Department: In-Process Quality Assurance (IPQA) / Quality Assurance
Job Type: Full-Time
CTC: ₹10 LPA – ₹15 LPA
JOB OVERVIEW
The Assistant Manager – IPQA is responsible for ensuring compliance with Good Manufacturing Practices (GMP) and Quality Management System (QMS) requirements during manufacturing operations. The role involves batch record review, shop floor quality assurance, documentation control, deviation management, change control, CAPA implementation, incident investigations, audit coordination, and cross-functional collaboration to maintain regulatory compliance and support high-quality manufacturing of biologics and pharmaceutical products.
KEY RESPONSIBILITIES
In-Process Quality Assurance (IPQA)
Perform shop floor IPQA activities during manufacturing operations.
Review batch manufacturing records and logbooks.
Verify line clearance and sampling documentation.
Ensure adherence to approved manufacturing procedures.
Monitor manufacturing activities for GMP compliance.
Documentation Management
Review production, warehouse, and engineering records.
Ensure accurate and timely QA documentation.
Verify completion of online documentation activities.
Maintain QA review records and documentation logs.
Ensure documentation complies with regulatory requirements.
Quality Management System (QMS)
Monitor compliance with Quality Management System (QMS) requirements.
Review and manage Change Control activities.
Support Incident Management processes.
Monitor Corrective and Preventive Actions (CAPA).
Ensure effective implementation and closure of QMS activities.
GMP Compliance
Verify compliance with Good Manufacturing Practices (GMP).
Monitor facility cleanliness and environmental conditions.
Ensure proper material segregation and status labeling.
Identify GMP deviations and initiate corrective actions.
Maintain inspection-ready manufacturing facilities.
Deviation & Investigation Management
Support investigations related to deviations and incidents.
Assist in investigations of batch failures and customer complaints.
Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
Collect investigation data and supporting documentation.
Participate in Root Cause Analysis (RCA).
CAPA Management
Coordinate CAPA implementation across departments.
Document corrective and preventive actions.
Track CAPA completion within agreed timelines.
Verify CAPA effectiveness.
Monitor ongoing compliance improvements.
Audit & Regulatory Compliance
Support internal and external GMP audits.
Coordinate audit preparation activities.
Provide documentation during regulatory inspections.
Track audit observations and action items.
Follow up on audit response implementation and closure.
Cross-Functional Collaboration
Coordinate with Production, Warehouse, Engineering, and QC teams.
Support supervisors during quality investigations.
Communicate quality issues across departments.
Participate in quality review meetings.
Drive continuous quality improvement initiatives.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
B.Pharm
Preferred
Postgraduate Degree in:
Microbiology
Quality Assurance
Biochemistry
Biotechnology
Pharmaceutical Sciences
Or a related discipline
EXPERIENCE REQUIREMENTS
Required
Minimum 7 years of experience in:
Manufacturing
Quality Assurance (QA)
In-Process Quality Assurance (IPQA)
Quality Control (QC)
Engineering & Development
Preferred
Experience in biologics or pharmaceutical manufacturing.
Experience working in GMP-regulated environments.
Experience managing CAPA, Change Control, and Deviations.
Experience handling regulatory audits and inspections.
Experience in CDMO or pharmaceutical manufacturing facilities.
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