Executive- clinical QA

Executive- clinical QA

Company: SCITUS PHARMA SERVICES

Job Location: Chennai, Tamil Nadu, India

Employment Type: Full-time

Company Description

Scitus Pharma Services Private Limited is a US FDAapproved organization providing clinical research services to pharmaceutical and biopharmaceutical companies. The company operates world-class Clinical Pharmacology units in India with over 110 beds and 12+ LC-MS/MS systems to support timely project execution. Scitus conducts Clinical Bioequivalence studies, Phase IIIV clinical trials, and comprehensive Clinical Data Management.

The organization also offers end-to-end pharmacovigilance services, from medical information call centers to aggregate report submission, risk assessment, and signal detection. With a team of experienced experts serving the US market and supporting lifecycle management for a growing portfolio of generic drug products, Scitus is committed to helping small and medium-sized companies meet evolving regulatory and safety demands.

About the Role

Role Description The Executive Clinical QA role is a full-time, on-site position based in Chennai. The individual in this role will perform routine quality assurance checks across clinical operations, including review of study documentation, protocols, and standard operating procedures to ensure compliance with regulatory and internal quality standards.

Responsibilities include participating in internal audits, supporting external and sponsor audits, monitoring corrective and preventive actions, and helping maintain and improve quality management systems. The Executive Clinical QA will collaborate closely with clinical, data management, and pharmacovigilance teams to identify process gaps, support training initiatives, and contribute to continuous quality improvement across projects.

Qualifications

Candidates should possess skills in Quality Control and Quality Assurance to monitor and maintain standards across clinical studies.

Candidates should possess skills in Quality Management and Quality Auditing to support robust quality systems, internal reviews, and regulatory inspections.

Candidates should possess knowledge related to Food Technology or related scientific disciplines, as well as broader life sciences understanding relevant to clinical research.

Relevant academic background such as a degree in Pharmacy, Life Sciences, Biotechnology, or a related field, with experience in clinical research or QA preferred.

Strong understanding of GCP, GLP, and regulatory guidelines (e.g., US FDA, EMA) and familiarity with SOP development and documentation practices.

Effective communication, analytical, and problem-solving skills, with the ability to collaborate in cross-functional teams and work with attention to detail. .