⚖️ Ensure Excellence in Biologics Development & Manufacturing
ORGANISATIONAL OVERVIEW
Lambda Therapeutic Research Ltd. is a Contract Development & Manufacturing Organization (CDMO) with a vision to provide integrated solutions for biologics drug development, GMP manufacturing, and First-in-Human (FIH) clinical trials globally. Our flexible capacity, agile approach, and end-to-end technical functions ensure quality, precision, and accelerated timelines from pilot batch to market.
🔬 JOB OVERVIEW
We are seeking an experienced Quality Assurance Specialist to uphold the highest standards of quality and compliance within our Analytical Development and Quality Control Laboratories. You will be responsible for reviewing critical records, ensuring adherence to QMS, supporting investigations, and maintaining GMP/GLP compliance—playing a vital role in the integrity of our biologics and biosimilars development pipeline.
📋 KEY RESPONSIBILITIES
📄 Documentation & Record Review
- Review test records, electronic audit trails, logbooks, method development/validation reports, and stability data.
- Ensure all QA documentation is completed online and aligned with the QMS reporting system.
- Oversee the issuance, availability, and adherence to approved SOPs within the Analytical Development and QC teams.
🛡️ Quality Management System (QMS) Compliance
- Monitor adherence to QMS elements: change control, incident management, and CAPA (Corrective and Preventive Actions).
- Verify that laboratories consistently meet GMP/GLP requirements, including facility conditions, material segregation, and status labeling.
- Initiate and follow QMS processes for any deviations or non-conformances.
🔍 Investigation & Root Cause Analysis
- Support supervisors in investigating complaints, batch failures, OOS/OOT results, and incidents.
- Coordinate cross-functionally to drive investigations, perform root cause analysis (RCA), document CAPA, and verify timely implementation and effectiveness.
- Collate data and conduct interviews to ensure thorough and compliant investigation processes.
📊 Audit Support & Compliance
- Assist in internal and external audit activities, providing necessary documents, clarifications, and records.
- Follow up with user departments to share audit responses and track the closure of audit action items.
- Maintain meticulous records of all audit-related activities and outcomes.
👤 YOUR PROFILE
✅ ESSENTIAL REQUIREMENTS
- B.Pharm. or Post-Graduation in Microbiology, Quality Assurance, Biochemistry, Biotechnology, or a related field.
- 7+ years of industrial experience in Manufacturing, Quality Control, Quality Assurance, or Engineering & Development within pharmaceuticals or biologics.
- Hands-on experience with GMP/GLP compliance, QMS, documentation review, and laboratory QA.
- Proven expertise in OOS/OOT investigations, CAPA management, and root cause analysis.
- Strong knowledge of analytical method development/validation and stability studies.
- Excellent coordination, communication, and attention to detail.
🌟 PREFERRED QUALIFICATIONS
- Experience in a CDMO or biologics/biosimilars environment.
- Familiarity with electronic documentation systems and audit trail reviews.
- Ability to work effectively in cross-functional teams and under regulatory scrutiny.
💼 WHY JOIN LAMBDA THERAPEUTIC RESEARCH?
- Impactful Role: Ensure the quality and compliance of cutting-edge biologics development and manufacturing.
- Career Growth: Advance within a forward-thinking CDMO dedicated to integrated, end-to-end solutions.
- Global Exposure: Contribute to First-in-Human trials and global regulatory submissions.
- Collaborative Culture: Work with agile, multidisciplinary teams in a science-driven environment.
- Professional Development: Gain expertise in biologics QA, QMS, and regulatory compliance.
🚀 READY TO UPHOLD QUALITY IN BIOLOGICS INNOVATION?
👉 APPLY NOW FOR THE QUALITY ASSURANCE SPECIALIST POSITION.
Lambda Therapeutic Research Ltd. is an equal opportunity employer committed to diversity, inclusion, and excellence in healthcare innovation.
