GCP Auditor Resume
Summary : As a GCP Auditor, planned conduct, and managed GCP (remote or onsite) and or other types of GXP audits under limited supervision, ensuring assigned audits are tracked appropriately, and submitted audit plan change control documentation as needed.
Skills : Regulatory Knowledge, Attention to Detail.
Description :
- Ensured audit observations are communicated appropriately to the Auditee and Senior Management.
- Ensured escalation process of critical observations.
- Prepared and distributed audit reports according to Alcon requirements and timelines.
- Reviewed, evaluated, and approved proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business partner.
- Provided guidance and advice to clinical teams on GCP-related questions.
- Tracked, trended, interpreted, and presented GCP compliance data for management metric review meetings and continuous improvement.
- Supported and prepared teams for regulatory inspections and/ or corporate audits as directed.
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree in Life Sciences
GCP Auditor Resume
Summary : As a GCP Auditor, entered and tracked Health Authority inspection information and reports in the database, mentored and trained junior auditors, and provided technical guidance, leadership, and coaching of audit-related activities.
Skills : Audit and Inspection Skills.
Description :
- Performed auditor certification process and assessments for new auditors.
- Provided guidance, review, and approval of associated deviations (NCI, & CAPAs).
- Led and supported the investigation of deviations and other quality issues detected from any source.
- Provided QA support to Supplier Evaluation Teams as needed and conducts GXP audits as assigned.
- Stayed current on activities in Clinical by reviewing the list of ongoing studies and attending Study Review and Project Kick-Off Meetings.
- Supported additional CQA initiatives and other cross-functional duties as assigned.
- Analyzed and monitored the key performance indicators of quality audits and liaised with the Quality Management System (QMS) team.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Nursing
GCP Auditor Resume
Headline : As a GCP Auditor advised and supported the audited structures in the development and implementation of corrective and preventive actions (CAPAs) to ensure regulatory compliance and accordingly do the validation and follow-up, participated in the preparation of inspections at the site or sponsor level as well as participate in the development and follow-up of the inspection responses.
Skills : Communication, Data Analysis.
Description :
- Took part in the development of the audit program, and interacted with the QMS Project Team Member, experienced in GVP is a plus.
- Operationalized approved audit plans and strategies for R&D GCP audits (External & Internal audits), considering relevant regulations and industry standards.
- Coordinated audit schedules and necessary resources with relevant stakeholders: Review documentation, procedures, and quality management systems before conducting audits.
- Performed on-site or remote audits (routine, for-cause/directed) and evaluated compliance with GCP regulations, internal quality standards, and relevant guidelines.
- Documented audit findings, deviations, and areas of non-compliance, Interviewed personnel, reviewed records and gathered evidence during audits.
- Prepared comprehensive audit reports outlining findings, observations, and recommendations for corrective actions.
- Ensured audit reports and corrective actions were developed and completed within timelines mandated in internal procedures and ensured effective CAPA was provided by the auditee, maintained well-organized and accurate audit documentation for regulatory and internal purposes.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Nursing
GCP Auditor Resume
Objective : As a GCP Auditor, responsible for maintaining audit files and operating process logs, responsible for reviewing and resolving compliance issues, and ensuring quality.
Skills : Problem-Solving, Ethical Conduct.
Description :
- Supported the process of developing audit programs for clinical studies and oversaw the programs every quarter or as required.
- Participated in & supported GCP, GVP & GLP authority inspections (FDA, EMA, PMDA, TGA, CFDI) in assigned roles such as back-room support, inspection hosting support, and inspection & pre-inspection preparation support (site and sponsor).
- Provided professional expertise and strong leadership in GCP guidance and regulations to internal stakeholders with R&D Quality and other functions within the company.
- Tracked record in conducting comprehensive Good Clinical Practice (GCP) audits.
- Contributed expertise in regulatory compliance, quality assurance, and auditing to ensure adherence to GCP standards in clinical trials.
- Escalated systemic, critical, and/or major audit findings and recommended appropriate solutions to senior management for immediate and long-term resolution.
- Worked with leadership to establish processes and standards for excellence in R&D audits, responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within R&D Quality and for R&D stakeholders.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Summary : As a GCP Auditor, responsible for presenting observations to appropriate representatives and preparing a written audit report. Experienced working in a clinical, regulatory, and quality assurance environment.
Skills : GCP Auditing, Regulatory Compliance.
Description :
- Organized and performed audits on internal systems as well as investigation on vendor audits.
- Developed and implemented new standard operation procedures.
- Created test materials and guidelines for clinical tests.
- Reviewed and revised legal contracts and quality agreements with vendors.
- Planned, scheduled, and conducted audit programs.
- Performed quality assurance on clinical and non-clinical documentation.
- Assessed compliance with regulatory requirements for clinical trial protocols and clinical quality management plans (CQMPs).
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Summary : As a GCP Auditor, responsible for conducting internal training sessions on GCP principles and compliance procedures. Monitored and tracked the progress of CAPA plans to ensure timely resolution of identified issues.
Skills : Quality Assurance, Risk Management.
Description :
- Assisted in the preparation for regulatory inspections by ensuring that documentation and processes comply with GCP standards.
- Provided support during regulatory inspections and responded to inspection findings as needed.
- Contributed to the development and maintenance of a robust QMS for clinical trials.
- Participated in the development and revision of SOPs related to GCP compliance.
- Provided GCP training to clinical trial staff, investigators, and other relevant personnel.
- Stayed informed about changes in GCP regulations and disseminated updates to the organization.
- Conducted risk assessments related to clinical trials and developed strategies to mitigate identified risks.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Headline : As a GCP Auditor, ensured that risk mitigation strategies were integrated into audit planning and ongoing monitoring activities, evaluated the effectiveness of audit processes, and recommend improvements to enhance efficiency and quality.
Skills : Clinical Trial Documentation, SOP Development.
Description :
- Stayed current with industry trends, regulatory changes, and best practices in GCP auditing.
- Maintained accurate and complete documentation of audit activities, including reports, correspondence, and CAPA records.
- Ensured that audit documentation was appropriately archived and accessible for regulatory inspections.
- Collaborated with clinical operations, data management, regulatory affairs, and other departments to ensure a unified approach to GCP compliance.
- Participated in cross-functional teams focused on quality improvement initiatives.
- Evaluated the ethical conduct of clinical trials, ensuring the protection of human subjects and compliance with ethical standards.
- Supported and contributed to the overall audit planning and scheduling process.
Experience
5-7 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Objective : As a GCP Auditor, Responsible for planning and conducting external audits of clinical studies and third parties, responsible for interpreting drug manufacturing procedures and applying GCP standards.
Skills : Training and Development, Cross-functional Collaboration.
Description :
- Responsible for performing internal audits within the affiliate and at Country Offices in the affiliating territories.
- Responsible for providing advice and implementing compliance issues and the Quality Management System (QMS).
- Responsible for performing assigned audits on internal GCP systems, external vendors, and clinical sites.
- Responsible for utilizing available information to provide well-informed audit findings and recommendations.
- Responsible for reviewing and verifying GCP reports.
- Responsible for evaluating requirements of the protocol, informed consent forms, case report forms, and essential documents.
- Responsible for assisting the Inspection Management Team in regulatory authority inspections.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Objective : As a GCP Auditor, responsible for maintaining documentation related to GCP compliance, audit findings, and corrective actions, responsible for supporting the development and implementation of quality management systems for clinical trials.
Skills : Regulatory Inspection Support, Excellent Communication Skills.
Description :
- Developed risk-based GCP audit plans for clinical trials, considering factors such as study complexity, critical processes, and regulatory requirements.
- Collaborated with cross-functional teams to ensure alignment of audit plans with project timelines.
- Performed on-site and remote GCP audits of clinical trial sites, investigator sites, vendors, and internal processes.
- Evaluated adherence to GCP regulations, study protocols, Standard Operating Procedures (SOPs), and applicable regulatory requirements.
- Prepared comprehensive audit reports detailing findings, observations, and recommendations.
- Communicated audit results to relevant stakeholders, including project teams, clinical site staff, and management.
- Worked with stakeholders to develop and implement corrective and preventive actions based on audit findings.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
GCP Auditor Resume
Objective : As a GCP Auditor, responsible for conducting GCP audits of clinical trial sites, ensuring compliance with regulatory requirements and company policies, responsible for preparing detailed audit reports, identifying non-compliance issues, and providing recommendations for corrective and preventive actions.
Skills : Clinical Research Expertise, Auditing Experience.
Description :
- Responsible for collaborating with cross-functional teams to develop and implement strategies for continuous improvement in clinical trial processes.
- Responsible for participating in regulatory inspections and supported the preparation of responses to regulatory findings.
- Responsible for leading the development and implementation of the clinical quality assurance program, including SOPs and training materials.
- Responsible for conducting risk assessments and developing risk-based audit plans for clinical trials.
- Responsible for providing training to clinical teams on GCP requirements, quality management, and compliance best practices.
- Responsible for coordinating with vendors and contract research organizations (CROs) to ensure their adherence to GCP standards.
- Responsible for assisting in the preparation and execution of GCP audits, including the review of study documentation and investigator site visits.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree in Pharmacy
