Immuneel Therapeutics is Hiring Trainee – Quality Assurance
A unique opportunity in Immuneel Therapeutics careers has arisen at Immuneel Therapeutics Pvt. Ltd. for the position of Trainee in Quality Assurance. Located in Bengaluru, Karnataka, this role invites applications from passionate individuals eager to contribute to the field of cell therapy and personalized immunotherapy.
About the Company
Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. The organization is committed to serving patients by connecting within, collaborating globally, and creating innovative solutions. Immuneel prides itself on a diverse and vibrant team that embraces best practices and innovations in the field of cell and gene therapy.
Job Details: Immuneel Therapeutics Careers
- Role Title: Trainee – Quality Assurance (Manufacturing Quality Assurance)
- Department/Function: Quality Assurance
- Reporting Structure:
- Reports to: Associate Director- Quality Assurance
- Direct Reports: Nil
Role Summary
The Immuneel QA trainee role is responsible for providing in-process quality oversight and supporting batch release activities to ensure compliance with cGMP and regulatory requirements. This role interfaces closely with Manufacturing, Quality Control, Facilities & Operations, Environmental Health & Safety (EHS), Regulatory Affairs, and internal QA teams to support QA operational requirements.
Key Responsibilities
- Perform In-Process Quality Assurance (IPQA) activities including dispensing verification, area clearance, line clearance, and material reconciliation in compliance with cGMP requirements.
- Review and approve manufacturing batch records (MBRs) and support release of Drug Substance (DS) and Drug Product (DP) batches for clinical and commercial use.
- Review batch packing records (BPRs) and ensure timely release of clinical and commercial batches in accordance with approved specifications and regulatory commitments.
- Assist in preparing, reviewing, and supporting approval of Annual Product Quality Review (APQR) reports in line with regulatory and internal quality system requirements.
- Execute Process Validation and Cleaning Validation protocols and reports, including deviation management and closure.
- Assist in developing and implementing qualification strategies for existing and new equipment in alignment with validation master plans and risk-based approaches.
- Assist in preparing, reviewing, and maintaining apex quality documents such as the Site Master File (SMF), Validation Master Plan (VMP), and Quality Manual.
- Preparation of User Requirement Specifications (URS) and execution of IQ, OQ, and PQ protocols and reports for equipment, utilities, and systems.
- Support the Document Control and Document Management System, including issuance, revision, archival, and retrieval of GMP documents.
- Initiate and review Quality Management System (QMS) documents, including SOPs, policies, and procedures related to manufacturing and quality operations.
- Prepare and review quality system documentation, including qualification and validation protocols, SOPs, study protocols, qualification summary reports, risk assessments, and deviation/failure investigation reports.
- Participate in internal audits, periodic system reviews, and regulatory inspections, and support implementation of continuous improvement initiatives for quality systems, processes, and workflows.
Qualifications
- Educational Qualification – B. Tech, M. Tech. B. Pharma, M. Pharm, M.Sc., in biotechnology/biopharmaceutical technology/biological sciences/quality assurance with relevant experience in quality assurance of biotech/biopharmaceutical products.
- Based on education, the Candidate should possess 0-2 years of previous experience in any Sterile pharmaceutical Manufacturing, biotech sector, including biosimilars/any other biological products. Cell and gene therapy experience will be preferred.
Working Conditions
- Role Type: Full-time and Onsite
- Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.
- Travel Requirements: Occasional travel, subject to requirements.
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Bangalore – 560099
How to Apply for the Immuneel QA Trainee Role
Interested candidates are encouraged to send their resume to careers@immuneel.com.
Conclusion
This Immuneel Quality Assurance role is an excellent opportunity for individuals looking to start their career in Quality Assurance at Immuneel Therapeutics. Candidates with the required qualifications and a passion for healthcare are encouraged to apply before the deadline.
