Quality Assurance Associate (CAR-T)
Quality Assurance Associate (CAR-T)
Posted on :
13-06-2025
Employer Active
1 Vacancy
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Job Description
We are currently seeking a highly motivated collaborative and experienced Quality Assurance (QA) personnel who can assist in establishing our CAR-T manufacturing GMP facility in Bangalore India. The ideal candidate should have prior experience in field of biologics and cell therapy. This is a multi-disciplinary role and candidate will interface across multiple parts of the company.
Responsibilities
- To assist in ensuring the quality management system and all aspects of cGMP are effectively established implemented and maintained in accordance with the regulatory and company standards.
- Provide QA oversight for all cGMP related activities (operations and QC)
- Review of quality system records such as change controls deviations complaints investigations and customer complaints.
- Partners with other functions in for ensuring QMS elements are complying to regulatory and company standards.
- Works closely with other functions in a cooperative fashion and ensure project progression.
- To provide QA oversight to the commissioning and qualification activities on site.
- Develop author review and/or approve standard operating procedures specifications regulatory filing information and other controlled documents as required.
- May participate in internal/external audits and regulatory inspections.
- Perform or support any other tasks necessary to maintain the product quality and cGMP compliance.
Behavioral skills:
- Communication: Clearly communicate with team members other departments and management to ensure efficient workflow and collaboration.
- Critical Thinking: Evaluate data and information critically to make informed decisions and optimize quality/operations processes.
- Problem-Solving: Ability to analyze complex issues and develop effective solutions to ensure compliance with regulations.
- Teamwork: Collaborate with colleagues and cross-functional teams to achieve common objectives and improve processes.
- Time Management: Prioritize tasks meet deadlines and ensure timely completion of projects while maintaining quality standards.
Qualifications :
- Bachelors degree or higher in Pharmacy or related life sciences field.
- 2 - 6 years of relevant experience in the biopharmaceutical or cell therapy industry.
- Experience with Cell and Gene therapy products preferred.
- Good knowledge of Good Manufacturing Practices.
- Familiarity and understanding of FDA EU and local industrial requirements.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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