Senior Technology Auditor, QA
Senior Technology Auditor, QA
PAREXEL7-9 Years
- Posted 20 hours ago
- Be among the first 10 applicants
Job Description
Key Accountabilities
Lead, Perform and Report audits
Perform other quality related task or initiatives as assigned
Lead, Perform and Report audits
- Independently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits (including GMP & GLP as well as GCLP accreditation audits), Trial Master File audit, safety/pharmacovigilance (PV) audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines.
- Perform and deliver high quality audits/audit reports within specified timelines / budgets, independently or with limited oversight. Lead or participate in complex audits including for-cause audits/ co-audits / observed audits with client representatives or other QA auditors.
- Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.
- For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.
- Travel internationally for audits as required. Travel time could be up to approx. 60%.
- Collect and review responses to audit findings and follow-up ! escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded.
- Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required.
- Coordinate internal global process/system audits across regions and develop all necessary tools such as report templates, checklists and standard emails.
- Report outcome and trends of audit program to the process owner, QA Senior Management.
- Escalate quality and compliance issue trends to QA Senior Management and relevant operational functions
- Resolve program related issues in a constructive and pro-active way.
- Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time.
- Review audit reports, responses and other program deliverables to ensure consistent high quality.
- Act as QA Lead on audits program(s)
- Arrange meetings with client and other key stakeholders as required to plan a program of contracted audits.
- Ensure required audits are delivered in accordance with clients requirements and Parexel! client procedures as applicable.
- Ensure that systematic issues raised during billable audits are escalated and addressed.
- Maintain relationships with clients and ensure audits programs are managed to a high degree of client satisfaction.
- Support client QA needs and identify areas where billable services may be offered.
- Develop and optimize new and existing processes to maintain and improve quality within the billable group.
- Support Serious Breaches (SB) investigations and help oversee the project teams to reach final conclusion regarding the reportability of a critical Quality Event.
- Support the training and mentoring of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.
- Assist in developing training materials, auditing tools, templates and guidance
- Provide QA Senior Management with informational reports upon request on assigned areas
- Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.
- Maintain current records / documents related to assigned areas
- Optimize new and existing processes to maintain and improve quality standards including supporting quality initiatives as assigned
- Support QA Management in development of audit plan, to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).
- Proactively recognize areas for process / procedural improvements, providing input to QA management and taking the initiative, as appropriate.
- Provide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.
- Support the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.
- Provide input on QA planning including audit planning and strategy as requested.
- Facilitate client audits / regulatory inspections, as assigned.
- Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of relevant GxP requirements across the Parexel Corporation
- Working knowledge and expertise of Parexel policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed.
- Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.
- Recognize, exemplify and adhere to Parexel values and standards
- Review Parexel SOPs as assigned to ensure GxP compliance of processes
- Maintain compliance with training curriculum.
- Build, develop, and maintain good working relationships with internal and external customer groups
- Work well in a team environment.
- Liaise with clients and operational staff on quality aspects which may include attendance of meetings, presentations and audits
Perform other quality related task or initiatives as assigned
- Ability to rapidly learn, understand and apply applicable Parexel and client procedures
- Ability to work flexible and across multicultural environment
- Ability to learn and use Parexel and client computer systems
- Client focused approach to work
- Ability to develop good working relationships with a culturally diverse group of Parexel and client personnel
- Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
- Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions
- Ability to mentor / train auditors and other personnel
- Excellent organizational, analytical, problem solving, decision making and negotiation skills
- Effective at analyzing problems considering the big picture and recommending appropriate corrective actions
- Ability to work independently and consistently in a fast-paced environment.
- Accurate and detail oriented, a critical thinker
- Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm
- A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
- Ability to diplomatically address sensitive issues confidentially and professionally
- Ability to work professionally with highly confidential information
- Team leadership abilities and positive attitude. Experience with using computer systems and software, including Microsoft Office
- Auditors must be detail oriented, good at decision making, able to maintain a big picture / overview on the project / business
- Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.
- Minimum of 4 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing
- At least 7 years experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
- Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
- Master's degree in a science, technology or industry related discipline, preferred.
More Info
Key Skills
About Company
Skills:
release management, Jira, User Stories, Devops, Software Delivery, Qa, Servicenow, executive summaries, cloud based technologies, data entitlement, audit-friendly AI documentation, source traceability, AI prompts, operational process improvement, acceptance criteria, business-ready recommendations, responsible AI governance, process maps
Skills:
Servicenow, release management, User Stories, Software Delivery, Jira, Qa, Devops, data entitlement, acceptance criteria, source traceability, responsible AI governance, operational process improvement, AI prompts, cloud based technologies, audit-friendly AI documentation, Data Validation, process maps, business-ready recommendations, executive summaries
Skills:
Qa, Devops, Jira, User Stories, Software Delivery, release management, Servicenow, executive summaries, cloud based technologies, data entitlement, audit-friendly AI documentation, source traceability, AI prompts, operational process improvement, acceptance criteria, Data Validation, business-ready recommendations, prompt design, responsible AI governance, process maps
Skills:
Data Visualization, Quality Assurance, 5 Whys Analysis, Project Management, Fish Bone Analysis, Process Improvement, Stakeholder Management