Job Title

Manager - Quality Assurance (QA) role in Bioequivalence studies ensures the integrity and reliability of research, focusing on compliance with regulations (GCP, GLP, GDP) and data integrity. The manager -QA is responsible for developing and implementing quality management systems, conducting audits and inspections, and reviewing documentation to ensure the study is conducted according to protocol. Key Responsibilities of a QA – manager in Bioequivalence Studies:Study Protocol Review: Evaluating the study protocol for scientific soundness and adherence to regulatory requirements. Clinical Conduct Monitoring: Ensuring the clinical phase adheres to the protocol, maintains subject safety, and minimizes variability. Analytical Method Validation: Verifying that analytical methods used to measure drug concentrations are accurate, precise, and reliable. Data Management and Integrity: Ensuring the collection, storage, and analysis of data are accurate and reliable. Audit and Inspection: Conducting audits of study activities, data, and reports, and managing sponsor audits for compliance. Document Control: Reviewing, approving, and maintaining documentation related to the study. Regulatory Compliance: Ensuring all study activities comply with regulatory guidelines. Preventing Errors: Identifying and preventing potential errors or deviations from the protocol. Continuous Improvement: Proposing and implementing improvements to processes and systems. Compliance with Good Practices: Ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP). Regulatory Submissions: Assisting with regulatory submissions by ensuring the data and documentation are accurate and complete. Skills and Qualifications:Knowledge of regulatory guidelines: Familiarity with GCP, GLP, GDP, and other relevant regulations. Understanding of Bioequivalence Studies: Knowledge of the principles and procedures of bioequivalence studies. Auditing and Inspection Skills: Experience in conducting audits and inspections to ensure compliance. Data Analysis and Integrity: Ability to analyze data for accuracy and integrity. Document Review and Control: Experience in reviewing and approving documentation. Problem-Solving and Critical Thinking: Ability to identify and resolve quality issues. Communication and Interpersonal Skills: Ability to communicate effectively with various stakeholders. Education: B. pharm / M. Pharm must require with A relevant 4-8 years of experience in CRO, irrelevant profiles / or fresher are not considered.