Quality Assurance Associate CAR-T
Quality Assurance Associate CAR-T
Posted on :
25-12-2024
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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 CART manufacturing GMP facility in Bangalore India. The ideal candidate should have prior experience in field of biologics and cell therapy. This is a multidisciplinary 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.
- ProblemSolving: Ability to analyze complex issues and develop effective solutions to ensure compliance with regulations.
- Teamwork: Collaborate with colleagues and crossfunctional 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 :
Fulltime
Employment Type
Full-time
Key Skills
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