Sr.Manager - R&D Quality GCP QA

Job Description:

Responsibilities

• Evaluate current systems and processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and Global Quality Systems/ SOPs (GQSs/ GSOPs) in collaboration with relevant stakeholders in R&D.
• Conduct the outsourced BA/BE study audits (both healthy volunteer and patient based) which include investigator site audits, Site Selection Visits (SSVs), Trial Master Files (TMFs) audits, study documents audits (Retrospective audits), In-process audits etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations and guidelines.
• Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) Qualification/ Re-qualification audits.
• Verify adequacy of all created & executed CAPAs, including CAPA identified as a result of audit by corporate audit department, followed by adequacy and effectiveness check of implemented CAPAs.
• Harmonize the QA systems and processes, wherever applicable and feasible, across the organization for in-house and outsourced BA/BE Studies.

Qualifiication & Experience

• Minimum graduate / post graduate degree in basic sciences
• Experience
• Tenure: At least 14 years of experience in GCP environment of which at least 06 years’ experience must be in Quality Assurance (QA).