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Life Sciences QA Jobs at Bio-Prospera Clinical Research Pvt. Ltd.
Job Title: QA Head – BA/BE Studies | QA Officer – BA/BE Studies (Clinical & Bioanalytical)
Company Name: Bio-Prospera Clinical Research Pvt. Ltd.
Location: Vasai (East), Mumbai, Maharashtra
Experience: 2+ Years
CTC: As per previous pay and interview performance
Job Type: Full-time, On-premise
About the Role:
Bio-Prospera Clinical Research Pvt. Ltd., a fast-growing CRO in India, is urgently hiring skilled professionals for Bioanalytical QA and Clinical QA roles. The ideal candidates will have strong experience in BA/BE studies, GxP compliance, auditing, and clinical research quality assurance.
Key Responsibilities:
Bioanalytical QA:
• Conduct internal and external audits of bioanalytical operations
• Ensure compliance with GLP, GCP, and GxP standards
• Review bioanalytical method validation and study documentation
• Monitor raw data, chromatographic data, and laboratory compliance
• Support sponsor audits and regulatory inspections
• Implement corrective and preventive actions (CAPA)
Clinical QA:
• Audit clinical operations and study conduct for BA/BE trials
• Review case report forms (CRFs), source documents, and trial master files (TMF)
• Ensure protocol adherence and regulatory compliance
• Support inspection readiness activities
• Identify quality gaps and implement CAPA measures
• Monitor clinical site compliance and documentation quality
Qualification Requirements:
• B.Sc / M.Sc / B.Pharm / M.Pharm / Pharm.D in Life Sciences or related fields
• Minimum 2+ years of experience in QA for BA/BE studies (clinical or bioanalytical) – mandatory
• Strong knowledge of clinical research, bioequivalence studies, and CRO quality systems
• Experience in document review, compliance auditing, and quality oversight
• Familiarity with GLP, GCP, GxP standards, and regulatory guidelines
• Excellent analytical, documentation, and communication skills
