Lead : Clinical Quality Assurance (FSP)

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Ensure compliance of clinical trials to protocol, standard operating procedures (SOPs), international conference on harmonization – good clinical practice (ICH GCP), project requirements and applicable regulatory requirements by conduct of various audits

Point of contact for assigned audits/ assigned projects from quality assurance (QA) function/ department.

Planning/ preparation for, conduct and reporting of various types of audits such as internal audit of various functions/ departments, project specific audits across various functions, investigational site audits, vendor audits, etc.

• Assist project team/ functions (auditee) to define root cause, corrections, corrective actions/ preventive actions ( CAPA), on need basis.
• Review of root cause, CAPA action items from various sources such as internal audits, project specific audits, external audits,
• certification audits, customer complaints/ escalations, regulatory inspections, etc.

Closure of audit reports after verification of supporting documents/ information evidencing implementation of CAPA action items. Follow-up for closure of audit reports, if required.

• Perform document control activities on need basis.
• Prepare and facilitate project team / various functions for external audits, certification audits and regulatory inspections.
• Prepare for and assist function head – QA for hosting and facing external audits , certification audits and regulatory inspections.
• Review of SOPs from various functions including QA.
• Assist function head – QA and other function heads to ensure that QMS is maintained and up -to-date with current changes/
• updates in industry and regulations.
• Provide GCP/ QA consultation to staff on need basis. 13. Develop new or revise existing QA SOPs and AD (administration/ corporate governance) SOPs, on need basis

Provide feedback for continuous improvement of quality management system (QMS). Communicate and coordinate with external stakeholders such as investigator/ site staff and sponsor for investigational site audits and vendors.

Prepare/ review and maintain documents related to internal audits, project specific audits, external audits, certification audits and QA function.

Liaise with sponsors and project managers on quality issues in studies/ projects including discussion on CAPA action items. Provide training to QA team, project team members / various functions on topics related to quality, audits, QA SOPs, essential AD SOPs, etc. on need basis.

• Proactively identify and communicate potential risks to auditee and function Head – QA for timely necessary actions / measures.
• Execute stand-alone QA services, on behalf of the sponsors.
• Assist function head – QA for response to RFIs/ RFPs, proposals, review of agreements and other QA governance/ oversight activities.
• Other responsibilities assigned by senior management and/ or function Head - QA