15 Sep
|
Intrinseque Health
|
New Delhi
15 Sep
Intrinseque Health
New Delhi
This role is responsible for overseeing quality assurance activities related to clinical supplies, equipment, and processes to ensure compliance with regulatory standards and internal quality systems. Day-to-day tasks include reviewing and implementing quality procedures, supporting audits and inspections, monitoring adherence to quality management frameworks, and documenting quality findings and corrective actions. The specialist collaborates closely with project management, operations, and regulatory teams to maintain consistent quality standards across clinical trials and supply chain activities.
The role also involves contributing to continuous improvement initiatives, training site and internal teams on quality requirements, and supporting risk assessment and mitigation for clinical quality operations.
Qualifications
- Strong foundation in Quality Assurance, Quality Control, and Quality Management, with the ability to apply these principles in a clinical and supply chain environment.
- Knowledge of Good Manufacturing Practice (GMP) and related regulatory guidelines relevant to clinical supplies and medical devices.
- Experience with Quality Auditing, including planning, conducting, and documenting internal or external audits and follow-up actions.
- Relevant academic background in life sciences, pharmacy, biomedical engineering, or a related discipline.
- Experience in clinical trials, clinical operations, or clinical supply chain quality is highly beneficial.
- Ability to interpret and implement international quality standards and work effectively in cross-functional teams.
- Solid analytical, documentation, and problem-solving skills, with attention to detail and integrity in data handling.
- Proficient in written and verbal communication in English; familiarity with quality management software or tools is an advantage.
📌 Quality Assurance, Clinical Specialist (New Delhi)
🏢 Intrinseque Health
📍 New Delhi