Clinical QA Job Opening For Life Sciences at MakroCare, Apply on Biotecnika
Job Title: Clinical Quality Assurance (CQA) – Associate
Company Name: MakroCare
Experience: 2+
CTC: Competitive; hike on current CTC or market-aligned package
Number of vacancies: 1
Rounds of interview: 2 rounds Virtual
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Location: Hyderabad, India
Job Summary:
We are seeking a detail-oriented and proactive Clinical Quality Assurance (CQA) Associate to join our Hyderabad team. The ideal candidate will ensure that clinical operations and processes comply with global quality standards, ISO guidelines, and ICH-GCP requirements. This role involves maintaining quality systems, conducting audits, supporting staff training, and contributing to continuous improvement initiatives within the organization.
Key Responsibilities:
• Maintain and update Standard Operating Procedures (SOPs), Quality Management System (QMS) documentation, Corrective and Preventive Actions (CAPAs), deviations, and audit records.
• Conduct internal audits and inspections to ensure compliance with ISO standards, ICH-GCP guidelines, and organizational policies.
• Assist in planning, executing, and reporting on clinical quality assurance activities.
• Identify areas for quality improvement and support the implementation of continuous improvement initiatives.
• Train and mentor clinical staff on quality standards, regulatory compliance, and best practices.
• Support external audits by regulatory authorities or clients and
• Collaborate with cross-functional teams to ensure adherence to quality processes in all clinical operations.
• Maintain up-to-date knowledge of industry regulations, guidelines, and quality practices.
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