Quality Specialist Complaints
New
IndiaFull-Time
Salary not disclosed
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Job Details
- Languages
- English
- Required Skills
- Quality Assurance
Requirements
- 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.
Responsibilities
- 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.
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