23 Aug
|
Expecto Health Science
|
Navi Mumbai
23 Aug
Expecto Health Science
Navi Mumbai
Company Description
Expecto Health Science (Southern Star Research Company) is a leading Clinical Research Organization headquartered in Singapore, providing comprehensive and cost-effective services across the Asia Pacific region. The organization specializes in Clinical Development, Data Management, Medical Writing, Regulatory affairs, and Pharmacovigilance, offering tailored solutions to diverse clients. Expecto Health Science is known for its Functional Service Provider (FSP) model, delivering strategic resourcing options to regional and global pharmaceutical partners in a cost-efficient manner. Its client portfolio includes innovators of new chemical entities and biologicals in early clinical development, small to mid-sized pharmaceutical and biotechnology firms with niche products, and medical device companies.
Role Description
The Head of Quality Assurance – Clinical Research is a full time, on-site role based in Navi Mumbai. This role is responsible for leading the QA function, designing and implementing quality systems and standards across clinical research operations,
and ensuring compliance with regulatory and GCP guidelines. Daily activities include overseeing internal and external audits, managing quality control processes, reviewing and approving SOPs, and driving continuous improvement initiatives in quality management. The role also involves collaborating with clinical, data management, regulatory, and pharmacovigilance teams to resolve quality issues, providing training on QA procedures, and reporting quality metrics and risks to senior leadership. The Head of QA will mentor QA staff, support client and regulatory inspections, and contribute to strategic planning for quality practices within the organization.
Qualifications
- Candidates should possess strong Quality Assurance and Quality Management skills, with experience establishing and maintaining robust QA frameworks in clinical research.
- Candidates should possess expertise in Quality Contro
📌 Head of Quality Assurance- Clinical research (Navi Mumbai)
🏢 Expecto Health Science
📍 Navi Mumbai