Lead : Clinical Quality Assurance (FSP)

Tech Observer; Mumbai; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Tech Observer in Mumbai seeks a QA Auditor to ensure clinical trial compliance with protocols, SOPs, ICH GCP and regulations through audits. You will plan, conduct, and report audits across functions, sites, and vendors, collaborating with QA to maintain high standards.

Key duties include root-cause analysis, CAPA development, audit closure with proper evidence, document control, and preparation for external audits and inspections. Training staff on QA processes is also required.

Responsibilities

• Ensure compliance of clinical trials to protocol, SOPs, ICH GCP and regulatory requirements through audits.
• Plan and prepare for internal and external audits across functions, sites and vendors.
• Conduct audits for investigational sites, vendors, and project-specific reviews.
• Assist auditees to define root cause, corrections, CAPA actions as needed.
• Review root cause and CAPA items from various sources and close audit reports with evidence.
• Perform document control activities related to audits and QA records.
• Prepare and facilitate teams for external audits, certification audits and regulatory inspections.
• Provide QA guidance and training to staff on quality, audits and QA SOPs.
• Identify potential risks and communicate with QA leadership for timely actions.

Job description

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,

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