Quality Specialist Complaints in India at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Quality Specialist – Complaints in India.
This role sits at the intersection of quality assurance, regulatory compliance, and customer safety within a pharmaceutical or healthcare environment. You will be responsible for ensuring that product quality standards are consistently upheld and that complaint handling processes are managed with accuracy and regulatory compliance. The position involves working closely with cross-functional teams including regulatory affairs, customer service, and medical information to assess and document product-related complaints. You will play a key role in identifying potential drug safety risks and ensuring timely escalation and investigation of quality issues. The environment is highly regulated and detail-oriented, requiring strong discipline and adherence to global quality standards. This role is ideal for professionals who are passionate about patient safety, compliance, and continuous improvement in quality systems. You will also contribute to strengthening local quality management systems in alignment with global standards.
- Develop, implement, and ensure compliance with quality plans and programs in line with internal and regulatory requirements.
- Support and coordinate regulatory inspections related to manufacturing and wholesale distribution licenses.
- Ensure implementation of regulatory compliance measures in collaboration with Regulatory Affairs teams.
- Monitor group quality standards and ensure their effective integration into the local Quality Management System (QMS).
- Record, assess, and document reported product complaints and potential drug safety or technical defect cases.
- Act as a key point of contact for Customer Service, Key Account Managers, Medical Information, and other internal stakeholders regarding complaints.
- Support investigation, escalation, and resolution of quality-related issues in a timely and compliant manner.
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline.
- Experience in quality assurance, pharmacovigilance, or pharmaceutical complaint handling is preferred.
- Strong understanding of GMP, GDP, and regulatory compliance frameworks.
- Ability to assess, document, and manage product complaints and quality incidents.
- Strong analytical and problem-solving skills with high attention to detail.
- Excellent communication and coordination skills for cross-functional collaboration.
- Familiarity with quality management systems (QMS) and regulatory inspection processes.
- Ability to work in a highly regulated and structured environment.
- Strong sense of accountability, compliance, and patient safety focus.
- Proficiency in English for documentation and stakeholder communication.
- Opportunity to work in a highly regulated global pharmaceutical quality environment.
- Exposure to international quality standards and regulatory frameworks.
- Strong focus on professional development in quality assurance and compliance functions.
- Collaborative, cross-functional working environment with global stakeholders.
- Opportunity to contribute directly to patient safety and product quality excellence.
- Structured work environment with clear processes and governance.
- Career growth opportunities within quality and regulatory domains.