Senior Quality Assurance Specialist – Emmes Group Hiring In Bengaluru
Emmes Group is hiring a Senior Quality Assurance Specialist in Bengaluru, India! If you have expertise in quality management, clinical research, and regulatory compliance, this is your opportunity to join a global leader in clinical research. With over 47 years of experience, Emmes is transforming cell and gene therapy, vaccines, and rare disease research. Apply today and contribute to advancing medical discoveries!
Company Overview:
Emmes Group is a global leader in clinical research, dedicated to advancing medical discoveries in cell and gene therapy, vaccines, and rare diseases. With over 47 years of experience, Emmes focuses on delivering high-quality research solutions that drive innovation and improve patient outcomes. Our collaborative culture fosters excellence, making us a trusted partner in the life sciences industry.
Job Overview
Job Post: Senior Quality Assurance Specialist
Location: India – Bengaluru
Category: Quality Assurance
Remote Jobs: No
Position Type: Regular Full-Time
Ref Id: 2294
Primary Purpose
The Senior QA Specialist will assist in guiding the direction of the Quality Management System and mentoring team members to ensure adherence to regulations and project requirements.
Responsibilities
- Conducts internal audits of projects, processes, clinical sites, monitors, deliverables, and departments of moderate to complex scope, requiring an in-depth evaluation and capacity to synthesize and apply information from one task or audit to another.
- Reviews documentation for accuracy and compliance (e.g., training records, test plans/scripts, CAPAs, quality incidents, audit reports, etc.).
- Reviews and tracks non-compliances, deviations, and CAPAs.
- Leads supplier/vendor qualification and evaluation.
- Leads client audits and regulatory inspections.
- Leads or participates in process improvement projects.
- Assists in or creates audit schedules for one or more portions of the Quality Management System (QMS).
- May also need to perform the below activities based on the role:
- Review and audit information security and computer systems verification and validation processes to identify potential security gaps and non-compliance.
- Ensure items documented on the plans of action and milestones (POAM) are aligned to a framework for security and privacy controls for information systems and organizations like the NIST SP 800-53 and others- as applicable.
- Review scan and evidence controls provided by the Information Technology department to ensure identified vulnerabilities are appropriately remediated in the specified time frame
- Conduct periodic assessments of information security controls, including remediation activities from FISMA/ ISO/ FEDRAMP/ other standard requisite audits.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences or related field
- Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO) with two to three years’ of auditing experience in the relevant field.
- Experience working in a regulated environment (e.g., GxP, ISO) and Familiarity with SDLC validation tools, including testing strategies like SAST and DAST and their use in identifying security vulnerabilities based on the role
- Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day-to-day basis as well as balance the unexpected needs of the company as they arise.
- Demonstrated organizational skills, high attention to detail, and ability to multi-task.
- Strong written and verbal communication as well as problem-solving skills.
- Microsoft Office proficiency.
- 4 years related experience, or a Master’s degree and 2 years related experience, or 6+ years of related experience for a Clinical QA OR Bachelor’s degree in computer science, software engineering, or a related field, and 4 years related experience, or a Master’s degree and 2 years related experience, or 6+ years of related experience in computer systems and/or information technology security auditing for a CSV QA role.
Keywords: Senior Quality Assurance Specialist, Quality Assurance, Clinical Research, Emmes Group, Quality Management System, Life Sciences, Computer Systems, Regulatory Compliance, Auditing
