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Quality Assurance

4 weeks ago

Bengaluru, Karnataka, India Immuneel Therapeutics Pvt. Ltd. Full time

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

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:

  1. 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.
  2. Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
  3. 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.
  4. 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

1. Role Title:

Quality Assurance

2. Department/Function:

Quality Assurance

3. Reporting Structure:

Reports to: Quality Assurance & Regulatory

Direct Reports: Individual Contributor

4. Role Summary:

Quality Assurance is responsible for in-process quality assurance and batch release activity. He/She will interface with the internal QA team, manufacturing, quality control, facilities operations, environmental health safety, and regulations to meet the QA operational requirements and compliance of cGMP requirements

5. Key Responsibilities:

List the main duties and responsibilities associated with the role. Be as specific as possible.

  1. IPQA related activity (dispensing, area clearance, line clearance and reconciliation of materials).
  2. Review of manufacturing batch record and release of DS/DP batches.
  3. Review of batch packing record and release the clinical / commercial batches.
  4. Preparation and review of APQR
  5. Process validation/Cleaning Validation Protocol preparation, execution, report closure and approval
  6. Strategy preparation for Qualification of Existing and New Equipment's,
  7. Review of apex documents (SMF, VMP and Quality Manuals)
  8. Design Review of Plant Layout & Facility Validation
  9. URS review, IQ OQ PQ execution, review and approval of reports
  10. Orientation & Training of personnel involved in aseptic activities
  11. Document control and Management System
  12. Review and approval of the documents of quality management processes and standard operating procedure
  13. Preparation of quality system documents such as qualification protocols, standard operating procedures, study protocols, qualification summary reports, risk assessment, failure/deviation investigation reports
  14. Providing cGMP training to various personnel on site
  15. Participation in periodic system reviews and quality audits, implementation of improvement projects for systems, process and workflow.

6. Primary Objectives:

Outline the key objectives the role is expected to achieve. These should align with the company's goals and strategic priorities.

  1. In-process manufacturing compliance of the clinical and commercial batches.
  2. Participation in QMS related activities, Deviation, change control, OOS, investigation, risk assessment
  3. To access and support in the implementation and qualification of digital platforms for QMS, LMS, TMS and DMS

7. Competencies Required:

Specify the skills, knowledge, and attributes necessary to perform the role effectively. This section can be divided into technical competencies and soft skills.

  1. Technical Competencies: Thorough understanding of IPQA and batch release activity
  2. Extensive knowledge in the sterile manufacturing, GMP, GLP and GDP of various regulated (FDA, EMA) and domestic markets.
  3. Through understanding of Qualification/validation procedures
  4. Thorough understanding of Deviation, Change Control, investigation, route cause analysis and CAPA
  5. Knowledge on data integrity, audit trials, ICH, and other regulatory guidelines.
  6. Exposure of work in 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 Skills

  1. Adaptable: Capable of adapting to evolving compliance requirements; flexible; can handle multiple tasks
  2. Team player: Work with a diverse or multi-disciplinary group to achieve a common goal
  3. Assertive: Confident & insistent in stating opinions
  4. Quality commitment : Has a consistent attitude and respect for high quality standards.
  5. Organized: Arranges work in an orderly way; has an orderly state of mind
  6. Persistent: Refuses to give up especially when faced with the opposition or difficulty; continues firmly or steadily
  7. Enthusiastic: Has an intense or eager interest in something; is ardent and positive in response
  8. Committed: Pledges oneself to a course of action and is willing to sacrifice to make it happen
  9. Continuous learner: Desire to learn continuously

8. Qualifications:

  • Educational Qualification –PhD, M.Tech. M. Pharm, 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 8-12 years of previous experience in biotech sectors including biosimilars/other biological products. Cell and gene therapy experience will be preferred.

9. Working Conditions:

Describe the working environment and any specific conditions related to the role (e.g. role type, work hours, travel requirements, physical demands etc.).

  • Role Type: Full Time
  • 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: Depends.
  • Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099