Lead : Clinical Quality Assurance

Tech Observer; Mumbai; In loco; INR 600.000 - 1.200.000; Tempo pieno

Descrizione del lavoro

Tech Observer is seeking a QA professional to ensure compliance with protocols, SOPs, ICH-GCP and regulatory requirements through audits. You will partner with QA and project teams to define root causes and implement CAPA actions, close audit reports, and assist external audits and inspections.

Responsibilities include preparing audit materials, reviewing SOPs, maintaining QMS, and providing QA guidance to staff to mitigate risks and ensure ongoing compliance.

Competenze

• Experience in planning and conducting internal audits and preparing audit reports.
• Knowledge of ICH-GCP, SOPs and regulatory requirements.
• Ability to define root cause, corrections and CAPA actions.
• Effective documentation and communication across QA and project teams.
• Auditing across functions and projects with attention to regulatory changes.

Mansioni

• Plan and conduct audits across functions and projects.
• Prepare and close audit reports with CAPA verification.
• Provide QA consultation for external audits and regulatory inspections.
• Review SOPs and maintain QMS in line with industry updates.
• Coordinate with auditees and sponsors on quality issues.
• Ensure document control is maintained as needed.
• Train teams on QA processes, SOPs and governance.

Descrizione del lavoro

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