Manager - Quality Assurance (QA)

The Manager - Quality Assurance (QA) role in Bioequivalence studies focuses on ensuring the integrity and reliability of research, with a strong emphasis on compliance with regulations such as GCP, GLP, and GDP, as well as data integrity. As the QA manager, your primary responsibilities include developing and implementing quality management systems, conducting audits and inspections, and reviewing documentation to ensure that the study is conducted according to the protocol. Key Responsibilities of a QA Manager in Bioequivalence Studies: - Study Protocol Review: Evaluate the study protocol for scientific soundness and adherence to regulatory requirements. - Clinical Conduct Monitoring: Ensure that the clinical phase adheres to the protocol, maintains subject safety, and minimizes variability. - Analytical Method Validation: Verify that analytical methods used to measure drug concentrations are accurate, precise, and reliable. - Data Management and Integrity: Ensure that the collection, storage, and analysis of data are accurate and reliable. - Audit and Inspection: Conduct audits of study activities, data, and reports, and manage sponsor audits for compliance. - Document Control: Review, approve, and maintain documentation related to the study. - Regulatory Compliance: Ensure that all study activities comply with regulatory guidelines. - Preventing Errors: Identify and prevent potential errors or deviations from the protocol. - Continuous Improvement: Propose and implement improvements to processes and systems. - Compliance with Good Practices: Ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP). - Regulatory Submissions: Assist with regulatory submissions by ensuring that 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 is a must with a relevant 4-8 years of experience in a CRO. Profiles that are irrelevant or from fresher candidates will not be considered for this role.,