Job Title: Assistant Manager – CDMO, Validation QA
Req ID: 1547
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 8,00,000 – 12,00,000 per annum
Job Type: Full-Time
Industry: Biopharmaceuticals / Clinical Research / CDMO / Quality Assurance
Experience Required: 7–10 Years
Education Required: MSc in Biotechnology/Biochemistry/Microbiology or M.Pharm in Quality Assurance
Organisational Overview
Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in India, delivering comprehensive clinical trial and biopharmaceutical development solutions. With over two decades of industry experience, the organization provides full-spectrum clinical research services to global pharmaceutical and biotechnology companies.
The company operates across multiple international locations and leverages advanced technologies, therapeutic expertise, and strong regulatory compliance frameworks to support safe, efficient, and high-quality product development. Lambda is committed to innovation, quality, and operational excellence, supported by a highly skilled global workforce.
Job Summary
The Assistant Manager – CDMO, Validation QA will be responsible for overseeing quality assurance activities related to validation, facility compliance, and quality management systems within a regulated biopharmaceutical manufacturing environment. The role involves reviewing qualification and validation documentation, ensuring adherence to Good Manufacturing Practices (GMP), supporting audit processes, managing quality investigations, and driving continuous quality improvement initiatives.
This position requires strong expertise in validation quality assurance, regulatory compliance, and cross-functional coordination within CDMO or biopharmaceutical operations.
Key Responsibilities
Review qualification, validation, requalification, and facility assurance documentation to ensure regulatory compliance.
Prepare and review Site Master File (SMF), Validation Master Plan (VMP), and other Quality Assurance documentation.
Review records maintained by warehouse, production, and engineering teams to ensure compliance with quality standards.
Ensure proper documentation practices and adherence to Quality Management System (QMS) procedures, including deviation reporting.
Manage issuance and implementation of approved procedures for manufacturing operations.
Verify compliance with QMS elements such as change control, incident management, and Corrective and Preventive Actions (CAPA).
Ensure manufacturing facilities consistently meet Good Manufacturing Practice (GMP) requirements, including facility conditions, material segregation, environmental monitoring, and status labelling.
Support investigations related to complaints, batch failures, incidents, and Out-of-Specification (OOS) or Out-of-Trend (OOT) results.
Coordinate with cross-functional teams to conduct root cause analysis, implement CAPA, and monitor effectiveness.
Support internal and external audit activities by providing documentation, clarifications, and audit responses.
Track audit observations, ensure timely closure of action items, and maintain quality records.
Required Skills and Competencies
Strong knowledge of validation and quality assurance processes in biopharmaceutical or CDMO environments.
In-depth understanding of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
Experience with deviation management, CAPA processes, change control, and incident investigations.
Strong documentation review and technical writing capabilities.
Excellent analytical, problem-solving, and root cause analysis skills.
Effective communication and cross-functional collaboration abilities.
Experience in regulatory compliance and audit management processes.
Experience Requirements
7–10 years of professional experience in Quality Assurance within a biopharmaceutical, biotechnology, or related regulated industry.
Demonstrated experience in validation QA, GMP compliance, and quality system management.
Educational Qualifications
MSc in Biotechnology, Biochemistry, or Microbiology, or M.Pharm in Quality Assurance.
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