Looking for a fulfilling career in biotech quality assurance? Immuneel Therapeutics is hiring Trainee QA (Manufacturing Compliance) professionals to support cell and gene therapy manufacturing. If you’re an M.Pharm or M.Tech graduate with a passion for ensuring quality in biopharmaceuticals, this role could be your perfect start!
About Immuneel Therapeutics: Innovating Cell and Gene Therapy
Immuneel Therapeutics is at the forefront of advancing cell and gene therapy to revolutionize treatment options for diseases like cancer. We specialize in developing CAR-T products and other innovative therapies, ensuring high-quality manufacturing and compliance. By joining our Quality Assurance (QA) team, you will have the chance to work in a dynamic environment, supporting life-changing products.
Key Responsibilities as a Trainee QA (Manufacturing Compliance)
As a Trainee QA, you will play a vital role in ensuring the smooth and compliant manufacturing of clinical and commercial batches. Below are the primary duties for the role:
- In-Process Quality Assurance (IPQA):
- Monitor dispensing, area clearance, line clearance, and material reconciliation activities.
- Provide real-time support during production processes to ensure compliance.
- Batch Record Review:
- Assist in reviewing manufacturing batch records for CAR-T products.
- Help with Drug Substance (DS) and Drug Product (DP) batch release processes.
- Annual Product Quality Review (APQR):
- Contribute to the preparation of APQR documentation.
- Audits and Inspections:
- Participate in internal audits to ensure alignment with regulatory requirements.
- Support inspections by regulatory bodies and implement corrective actions.
- Collaboration Across Teams:
- Work with manufacturing and QA teams to address deviations, out-of-spec (OOS) results, and risk assessments.
- Compliance Documentation:
- Maintain detailed records of all quality-related activities following industry best practices.
Desired Qualifications and Skills
This role is ideal for fresh graduates or candidates with minimal experience. Here are the key qualifications and skills:
- Educational Qualification:
- M. Pharm (Quality Assurance)
- M. Tech in Biopharmaceutical Technology / Biological Sciences
- Key Skills:
- Interest in biopharmaceuticals and biotech quality assurance.
- Strong attention to detail and the ability to maintain organized records.
- Basic understanding of regulatory standards for cell and gene therapy.
- Willingness to work in shifts if required.
Why Join Us?
- Be a part of an innovative biotech company working on cutting-edge therapies.
- Opportunity to gain hands-on experience in manufacturing compliance and quality assurance.
- Work alongside experts in the field of CAR-T therapy.
How to Apply for the Trainee QA Position
Are you ready to kickstart your career in quality assurance? Submit your application by following these steps:
- Prepare your updated resume highlighting relevant skills and experience.
- Email your profile to: careers@immuneel.com
- Subject line: “Application for Trainee QA (Manufacturing Compliance)”
