Trainee – Quality Assurance (Manufacturing Quality Assurance)

Immuneel Therapeutics Pvt. Ltd.; Bengaluru; On-site; INR 240,000 - 360,000; Full time

Job summary

Immuneel Therapeutics Private Limited seeks a Trainee in Quality Assurance (Manufacturing QA) to provide in-process quality oversight and support batch release, ensuring compliance with cGMP and regulatory requirements. This role collaborates with Manufacturing, QC, Facilities, EHS, Regulatory Affairs, and QA teams to maintain product quality.

The trainee will review MBRs/BPRs, support APQRs, and assist in qualification activities for equipment and digital QMS platforms.

Qualifications

• In-process Quality Assurance (IPQA) activities as per cGMP requirements.
• Review and approval of manufacturing batch records (MBRs) and BPRs.
• Prepare, review, and support APQR reports.
• Execute validation protocols (IQ/OQ/PQ) and risk-based approaches.
• Develop and implement qualification strategies for equipment under validation plans.
• Maintain Site Master File (SMF), VMP, and Quality Manual.
• Prepare URS and associated qualification documents.
• Support QMS documentation and SOPs, change controls, and CAPA.

Responsibilities

• Perform IPQA activities including dispensing verification and area clearance.
• Review MBRs for clinical and commercial batches.
• Review BPRs and ensure timely release per specs.
• Assist in APQR preparation and regulatory alignment.
• Execute validation protocols for equipment and utilities.
• Support digital platforms for QMS, LMS, TMS, and DMS.
• Contribute to internal audits and regulatory inspections.
• Assist continuous improvement initiatives in QA processes.

Skills

IPQA

GMP

QA Oversight

Documentation

Data integrity

Audits

CAPA

QMS

Education

Bachelor or Master in Biotechnology/QA

Tools

ELN

ICS

EQS

LMS

DMS

Job description

Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com

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.

Working at Immuneel promises the excitement of an agile startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:

• Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
• Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
• Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
• Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.

If you are a talented professional, an out-of-the-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.

1. Role Title:

Trainee – Quality Assurance (Manufacturing Quality Assurance)

2. Department/Function:

Quality Assurance

3. Reporting Structure:

• Reports to: Associate Director- Quality Assurance
• Direct Reports: Nil

4. Role Summary:

The Trainee Quality Assurance (Manufacturing Quality Assurance) 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. The analyst ensures adherence to approved procedures, monitors manufacturing activities, reviews and approves GMP documentation, and supports investigations, deviations, and corrective actions to maintain product quality and compliance throughout the manufacturing lifecycle.

5. 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.

6. Primary Objectives:

• In-process manufacturing compliance ofthe clinical and commercial batches
• Participation in the 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 and DMS
• Thorough understanding of IPQA and batch release activity
• Knowledge in the sterile manufacturing, GMP, GLP and GDP of various regulated (FDA, EMA) and domestic markets.
• Through understanding of Qualification/validation procedures
• Thorough understanding of Deviation, Change Control, investigation, root cause analysis and CAPA
• Knowledge of data integrity, audit trails, ICH, and other regulatory guidelines.
• Exposure to work in a Digital QMS environment, i.e. Electronic systems – ELN (Electronic lab notebook), ICS (Instrument calibration system), EQS (Equipment Qualification system), IMS (Inventory management system), LMS (Learning Management system), QMS (Quality management system), DMS (Document management system).
• Soft Skills:
• Interpersonal SkillsAdaptable: Capable of adapting to others and new situations; flexible; can handle multiple tasks
• Team player: Works well with a diverse or multi-disciplinary group to achieve a common goal
• Assertive: Confident or insistent in stating opinions or claiming rights without infringing on others.
• Quality commitment: Has a consistent attitude and respect for high-quality standards.
• Organized: Arranges work in an orderly way; has an orderly state of mind
• Persistent: Refuses to give up, especially when faced with opposition or difficulty; continues firmly or steadily
• Quick Study: Can master a Situation or learn new things faster than contemporaries
• Judgment: Able to formulate opinions, compare and decide, has good sense
• Enthusiastic: Has an intense or eager interest in something; is ardent and positive in response
• Committed: Pledges oneself to a course of action and is willing to sacrifice to make it happen
• Continuous learner: unusual desire to learn continuously, develop oneself and keep current

8. 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 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.

9. 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.