About ICBio Clinical Research Pvt. Ltd.: Headquartered in Bengaluru, India, ICBio is a full-service Contract Research Organization (CRO) with over 16 years of experience in conducting Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. We have successfully completed over 1,000 BA/BE studies and approximately 500 clinical trials. Our services are approved by several global regulatory bodies, including ANVISA Brazil, DCGI, CDSCO, MHRA, UAE MOH, GCC, MOH Kazakhstan, and Zambia . Our NABL-accredited central laboratory is fully integrated with LIMS, ensuring high-quality data and compliance. Our Services Include: Bioavailability/Bioequivalence Studies Phase I–IV Clinical Trials Bioanalytical Services Regulatory Affairs and Dossier Preparation Pharmacovigilance Clinical Data Management and Biostatistics Medical Writing job responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOP’s are available in work place. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Ensure computerized systems used in the studies has been validated as per the regulatory requirement. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. Approve the individual sample repeats, ISR and investigation of batch failures. In case of any deviation from the protocol, assess and document the impact on the quality and integrity of the study and take appropriate corrective action when necessary. Ensure regular instruments backup and study related documents are archived properly. Show more Show less
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.
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.,