Freshers BSc Life Sciences Jobs in QA at Clinica Research
Job Role: Quality Assurance Associate
Company: CLINICA research
Location: Navi Mumbai
Qualification: Bachelor’s degree in life sciences or related field; or equivalent combination of education, training, and experience
Experience: 0–1 year
Salary: ₹20,000 per month
Essential Duties and Responsibilities:
• To determine whether all trial related activities were conducted, data recorded, analysed and reported accurately & in compliance to protocol, SOPs, GCP and applicable regulatory requirements.
• Internal audits of clinical research procedures, systems and personnel records of CLINICA.
• Clinical site audits to evaluate site activity in compliance to protocol, SOPs, ICH-GCP & applicable regulatory guidelines.
• Database audits to inspect the data cleaning process.
• Facilitating external audits/inspections conducted by sponsors, clients.
• Assess internal trial master files and site-specific files in compliance to protocol, SOPs, ICH-GCP & applicable regulatory guidelines.
• Perform audits at various stages of project conduct and resolutions of Corrective Actions and Preventive Actions (CAPA) items and deviations as assigned.
• Maintain company auditing SOPs and make the necessary updates.
• To maintain confidentiality of clients/project and related information as applicable.
• Maintain records of Audits Trials, Audit Reports and Audit Certificates.
• Provides GCP guidance to internal departments for all phases of clinical
• Coordinating the revision of SOPs, ensuring training, tracking of distribution and archival of SOPs.
• Providing leadership as an author or reviewer in the development of QA controlled documents (e.g., SOPs, plans, guidelines and working practice document) as per the SOPs, or as determined in conjunction with management.
• Contributing to the conduct of computerized system validation activities.
• Developing and implementing a Vendor Audit Plan.
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