Senior Research Associate

ORGANISATIONAL OVERVIEW

JOB DETAILS

• To conduct retrospective audits of raw data, chromatographic data, report, applicable sections of clinical study report of studies as per the regulatory guidelines, in-house SOPs, method SOP, study plan and protocol and to prepare its quality assurance statement.
• To conduct retrospective audits for Bio-analytical method validation and addendum to method validation (raw data & report) as per method validation guidelines and in-house SOPs, MV plan and to issue quality assurance statement.
• To review Bio-analytical study plan, method validation plan, method SOP and its relevant protocol sections.
• To plan and conduct in-process audits of various bio-analytical phases for studies/projects and method validation and its addendum.
• To conduct retrospective audit of IQ/OQ/PQ and external calibration data of various instruments.
• To conduct process-based audits and system audits of various sections of bio-analytical department as well as QA department as per schedule and share its audit reports.
• To review responses to regulatory or sponsor deficiency letters/queries / audit reports/ audit observations.
• To act as Lead Auditor during conduct of System Audit.
• Preparation, Review and Approval of Audit Plan.
• To upload and review the data in e-TMF.
• Archiving and Retrieving of Non-Project study specific documents in the archives.
• To perform QA functions as per OECD GLP principles and to ensure its compliance.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

EDUCATIONAL QUALIFICATION

COMPETENCIES