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BSc Life Sciences Jobs – QA Role at Emmes Group
Emmes Group is seeking a dedicated Quality Assurance Specialist in Bengaluru to ensure excellence in clinical research operations. This QA role involves auditing, validation, and regulatory compliance, providing an opportunity to contribute to life-changing medical discoveries while advancing your career in a collaborative and innovative environment. Various BSc Life Sciences Jobs are offered for candidates to enhance their QA Journey!
QA Role Details:
- Location: Bengaluru, India
- Job Type: Regular Full-Time
- Department: Quality Assurance
- Experience Required: Minimum 1 year in QA in a regulated environment
About Emmes Group:
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. With over 47 years of experience, Emmes Group has established itself as a leading provider in clinical research, focusing on areas such as cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. They are dedicated to making a direct impact on patients’ lives and are committed to fostering a collaborative culture that drives both performance and people.
QA Role Purpose:
The QA Specialist assists the QA Department in maintaining the quality system by reviewing validation documentation for computerized systems and applications, conducting audits, and supporting various quality management activities.
Educational Requirements:
- Bachelor’s degree in Life Sciences or related scientific field.
- Quality certifications preferred (e.g., CQA, RAC, RQAP).
Key Responsibilities of the QA Role:
- In this QA Role, you have to support Emmes’ proprietary Veridix AI and commercial software used in clinical trials.
- Review and audit computer system validation and verification documentation.
- Conduct internal audits of projects, processes, clinical sites, and deliverables.
- Review documentation for accuracy and compliance (training records, CAPAs, audit reports, quality incidents, project documents).
- Track non-compliances, deviations, and CAPAs.
- Support supplier/vendor qualification and evaluation.
- Participate in client audits and regulatory inspections.
- Lead or support process improvement projects.
- Write and review corporate SOPs and policies.
- Conduct trainings as needed.
- Perform other assigned duties.
Skills Required for the QA Role:
- Strong auditing and validation skills.
- Knowledge of 21CFR Part 11/EU Annex 11, GAMP 5; familiarity with NIST SP 800-53 and FISMA is a plus.
- Detail-oriented and compliance-focused.
- Effective documentation and communication skills.
- Ability to collaborate across teams and projects.
How to Apply?
Visit the Emmes Group careers page to submit your application and stay updated on job alerts.
