applications for the Quality Specialist position in India. The role focuses on Quality Assurance (QA), GxP compliance, electronic Quality Management System (eQMS) activities, deviation investigations, Corrective and Preventive Actions (CAPAs), and audit support.
Candidates with a bachelor’s degree or relevant work experience and at least two years of experience in a Quality Assurance role can apply. Experience with GxP Quality Management Systems and CAPA management is preferred.
Recruitment 2026: Job Details
| Particulars | Details |
|---|---|
| Job Title | Quality Specialist |
| Location | India |
| Job Type | Full-time |
| Experience | Minimum 2 years in Quality Assurance |
| Qualification | Bachelor’s degree and/or appropriate relevant work experience |
| Job Requisition ID | JR10726 |
| Work Arrangement | Remote work supported; hybrid working may be encouraged for employees within a reasonable commute of an office, as agreed with the manager |
Position
Quality Specialist
The selected candidate will support quality management activities, maintain GxP compliance, manage deviations and CAPAs, coordinate audits and regulatory inspections, and prepare quality reports and performance metrics.
Responsibilities
Key responsibilities of the Quality Specialist include:
- Maintaining compliance with applicable GxP guidelines and regulations.
- Supporting eQMS activities, including change control, deviations, quality events, CAPAs, and effectiveness checks.
- Developing, recommending, and monitoring deviations, quality events, and CAPAs.
- Reviewing and communicating root-cause analyses and CAPAs to stakeholders.
- Performing effectiveness checks to evaluate CAPA implementation.
- Participating in GxP change management, including risk and impact analysis, change plan reviews, action plan implementation, and completion tracking.
- Supporting client audits and regulatory inspections, including questionnaire coordination, agenda finalization, document provision, and internal logistics.
- Coordinating audit CAPA responses with relevant subject matter experts.
- Tracking audit and inspection records in the eQMS through closure.
- Maintaining audit information and records in the eQMS.
- Preparing reports on quality activities and their outcomes.
- Investigating deviations and quality events to identify quality system improvements.
- Collecting, managing, and analyzing data related to CAPAs, deviations, quality events, and quality KPIs.
- For Medical Information QA activities, retrospectively evaluating telephone skills and case reports to verify compliance with applicable standards.
Eligibility and Qualifications
Candidates applying for the Quality Specialist job should meet the following requirements:
- A university or bachelor’s degree, and/or appropriate relevant work experience.
- At least two years of experience working in a Quality Assurance role.
Preferred experience:
- Handling deviations, quality events, CAPAs, and effectiveness checks.
- Working with GxP Quality Management Systems.
- Quality record management, reporting, and data analytics.
- Medical Information Quality Assurance, particularly assessing telephone calls in a call center.
Required Skills
Applicants should possess the following skills:
- Fluency in written and spoken English.
- Knowledge and experience with GxP Quality Management Systems.
- Proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
- Strong organizational, prioritization, project management, and delegation skills.
- Ability to multitask and maintain excellent attention to detail.
- Strong verbal, written, and interpersonal communication skills.
- Ability to build professional relationships with clients, quality teams, internal staff, and management.
- Excellent customer service skills.
- Ability to collaborate across departments and adapt to change.
- Proactive working style and ability to work with minimal supervision.
