This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Specialist Complaints based in India.
This role plays a key part in ensuring product quality, patient safety, and regulatory compliance within a pharmaceutical environment. You will be responsible for overseeing complaint handling processes and ensuring timely, accurate assessment of product-related issues. The position involves close collaboration with cross-functional teams including regulatory affairs, customer service, and medical information. You will help maintain and strengthen the Quality Management System (QMS) while ensuring alignment with global and local quality standards. The role also includes supporting regulatory inspections and contributing to continuous improvement initiatives. It is a highly collaborative and detail-oriented position with strong impact on compliance, safety, and operational excellence.
Accountabilities:
- Develop, implement, and maintain quality plans and programs in alignment with internal and regulatory requirements
- Coordinate and support regulatory inspections related to manufacturing and wholesale distribution licenses
- Ensure compliance with applicable regulations in close collaboration with the Regulatory Affairs Manager
- Monitor Group quality standards and ensure effective implementation within the local Quality Management System (QMS)
- Record, assess, and document reported cases of drug-related risks or suspected pharmaceutical quality defects
- Act as a key point of contact for complaint handling in collaboration with Customer Service, Key Account Managers, Medical Information, and other internal stakeholders
Requirements:
- Degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline
- Experience in Quality Assurance, Quality Control, or Pharmacovigilance within the pharmaceutical industry
- Strong understanding of GMP, GDP, and regulatory compliance frameworks
- Experience in handling product complaints and quality incident investigations
- Excellent communication skills with the ability to work across cross-functional and international teams
- Strong analytical mindset, attention to detail, and problem-solving abilities
- Proficiency in documentation systems and Quality Management Systems (QMS)
Benefits:
- Competitive compensation package aligned with industry standards
- Health and wellness benefits including medical coverage
- Opportunities for professional development and training
- Exposure to international quality and regulatory frameworks
- Collaborative and cross-functional working environment
- Potential flexibility in working arrangements depending on role requirements