Analyst Quality Assurance Job – at Immuneel, Apply Now!
Are you ready to be part of the next revolution in cancer treatment? Immuneel Therapeutics Pvt. Ltd. is hiring an Analyst – Quality Assurance (Analytical Quality Assurance) in Bengaluru. This exciting opportunity offers a chance to contribute to cutting-edge cell and gene therapy, ensure analytical compliance for clinical and commercial batches, and support quality management systems—all while working in a dynamic, purpose-driven environment.
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.
We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.
About the job
Role Title: Analyst – Quality Assurance (Analytical Quality Assurance)
Department/Function: Quality Assurance
Reporting Structure:
Reports to: Quality Assurance
Direct Reports: Individual Contributor
Role Summary:
Analytical QA is responsible for in-process and batch QC activity. He/ She will interface with the internal QA, manufacturing, quality control, facilities operations, environmental health safety, and regulatory to meet the Analytical QA requirements and
compliant to cGMP requirementsKey Responsibilities:
- Analytical Quality Assurance and development quality assurance
- Review of specification, STP & ATR of raw material, packaging/Consumable material, in process, DS, DP finished product and stability samples
- Review of CoA for raw material, packaging/consumable material, in process, DS, DP finished product and stability samples
- Review of Environmental Monitoring ATR and OOT
- Review and assist in Analyst Qualification and its documentation
- Review and assist in Method Transfer, Method Validation and its associated documentation
- Preparation and review of the documents as per quality management processes such as standard operating procedure, Change controls, OOS, risk assessment, failure/deviation investigation reports
- Participation in periodic system reviews and quality audits, and implementation of improvement projects for systems, processes, and workflow
- CSV knowledge and GAP assessment
- Stability studies for biologics
- Calibration and validation of QC equipment
- Facility requirements for Molecular biology, Bioassay, Microbiology, RM/PM/CM and other QC Laboratory
Primary Objectives:
- Analytical compliance of the clinical and commercial batches
- Developmental analytical assurance
- Participation in QMS related activities, Deviation, change control, OOS, investigation, risk assessment
- To access and support in the implementation and qualification of digital platforms for QMS, LMS, TMS, LIMS, and DMS
Competencies Required:
Technical Competencies:
- Understanding of AQA and batch release activity for Biopharmaceutical manufacturing
- Knowledge of sterile manufacturing and testing, GMP, GLP and GDP of various regulated (FDA, EMA) and domestic markets
- Understanding of Deviation, Change Control, investigation, route cause analysis and CAPA
- Knowledge of ALCOA++ principles, audit trials, ICH, and other regulatory guidelines
- Exposure of work in Digital QMS. LMS (Learning Management system), QMS (Quality management system), DMS (Document management system)
Soft Skills for Analyst Quality Assurance Job:
- Adaptable
- Team player
- Assertive
- Quality commitment
- Organized
- Persistent
- Quick Study
- Judgment
- Enthusiastic
- Committed
- Continuous learner
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 upon education, the candidate should possess 1-2 years of previous experience in any biotech sector. Freshers with relevant academic projects are eligible.
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: whenever required
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore
If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.
Interested to be a part of the next revolution in cancer treatment? Send your resume to [email protected]
Keywords: Analyst – Quality Assurance, Quality Assurance, Biopharmaceutical, GMP, GLP, Quality Management, Biotechnology
