Manager - Quality Assurance (QA) in Bioequivalence studies

Manager - Quality Assurance (QA)

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.