Immuneel Freshers Trainee QA Jobs – BSc, MSc Apply Online
Immuneel Freshers Trainee QA Jobs – BSc, MSc Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Trainee – Quality Assurance
Bengaluru, Karnataka, India
About the job
About Immuneel
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 start-up 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 prides itself as an organization that is keeping pace with best practices in organization design. Our role-based organization incorporates global trends in human capital that promote focus on work and greater nimbleness. Our role-based structure allows you to be cherished by the work you do and bring value to your work rather than designations, our organization is simplified into a flat, non-hierarchical, millennial, organization where you may fully inherit the role you play in the organization and are recognized by the accountability you take and the work you deliver.
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-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].
1. Role Title: Trainee – Quality Assurance (Documentation Management System)
2. Department/Function: Quality Assurance
3. Reporting Structure:
Reports to: Quality Assurance
Direct Reports: NA
4. Role Summary:
The Trainee QA (Documentation Management System) is responsible for the creation, control, distribution, and archival of GMP-compliant documentation within a regulated manufacturing environment. This role ensures that all controlled documents such as Standard Operating Procedures (SOPs), batch records, protocols, and reports are maintained following applicable regulatory standards (e.g., Schedule- M, USFDA, EMA) and internal quality systems. The Document Management professional plays a key role in supporting data integrity, document traceability, and audit readiness, ensuring that the documentation lifecycle aligns with GMP requirements.
5. Key Responsibilities:
- Manage and control the full lifecycle of documentation, ensuring proper issuance, distribution, archival, retrieval, and disposal of controlled documents.
- Oversee the issuance, tracking, and maintenance of key GMP documents including logbooks, laboratory notebooks, Batch Manufacturing Records (BMRs), Certificates of Analysis (COAs), and other quality-critical records.
- Ensure proper issuance of Controlled Copies, Uncontrolled Copies, and Reference Copies as per the organization’s document control procedures.
- Maintain compliance with data integrity standards by ALCOA+ principles across all documentation practices and systems.
- Coordinate the issuance and control of Quality Management System (QMS) documents such as Change Controls, Deviations CAPAs, etc.
- Allocate and maintain a standardized numbering system for Standard Operating Procedures (SOPs) across all departments.
- Ensure timely availability and traceability of all documentation to support audits, inspections, and operational needs.
- Monitor document review schedules to ensure timely updates and revisions of SOPs, manuals, and policies following regulatory and internal timelines.
6. Primary Objectives:
Periodic Review and Revision Control:
Monitor document review schedules to ensure timely updates and revisions of SOPs, manuals, and policies by regulatory and internal timelines.
Document Training Coordination:
Ensure that updated documents are communicated to relevant personnel and training records are maintained for all revised or newly issued controlled documents.
Cross-functional collaboration:
Work closely with QA, QC, Manufacturing, R&D, and other departments to ensure proper documentation issuance and retrieval are followed across the organization as per the TAT.
Audit Support and Compliance:
Support internal and external audits by providing requested documentation promptly. Ensure readiness for inspections by maintaining version control.
Retention and Disposal Management:
Ensure documents are stored and disposed of according to approved retention schedules and regulatory requirements.
Confidentiality and Access Control:
Maintain confidentiality and restrict access to sensitive documentation based on user roles and responsibilities
7. Competencies Required:
Technical Competencies:
- Knowledge of GMP Regulations
- Understanding of Good Manufacturing Practices (GMP) as per regulatory agencies and understanding of GDP (Good Documentation Practices) and their critical role in maintaining product quality and compliance.
- Documentation Lifecycle Management
- Skilled in managing the full lifecycle of controlled documents—from creation, review, issuance, archival, and retrieval, to disposal as per GMP guidelines.
- Maintains document traceability and version control in alignment with audit and inspection readiness.
- Organizational and Time Management Skills
- Capable of managing high volumes of critical documents across multiple departments (QA, QC, Manufacturing, Facility, etc.).
- Meets deadlines for issuance, review, and control in support of manufacturing timelines.
Soft Skills:
- Self-motivated
- Self-confident
- Adaptable
- Ethical
- Customer-oriented
- (Manages) stress
- Detail-oriented
- Quick Study
- Enthusiastic
- Initiative
8. Qualifications:
Educational Qualification:
- Bachelor’s degree in a relevant field such as Pharmacy (B. Pharm/M. Pharm), Life Sciences (Biotechnology, Microbiology, Biochemistry, etc.), or Chemistry.
- Candidate should possess a graduate or postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related field, with 0–2 years of prior experience in QA or Documentation within the pharmaceutical or biotech sector, including biosimilars or other biological products; experience in Cell and Gene Therapy will be considered an added advantage.
Editor’s Note: Immuneel Freshers Trainee QA Jobs – BSc, MSc Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
