When our values align, there's no limit to what we can achieve. As a Senior Technology Quality Assurance (TQA) Auditor you will have the experience and knowledge to provide guidance and facilitate the effective preparation, conduct and follow up of internal and supplier technology audits.
You will exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.
The TQA Senior Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.
Technology Quality Auditors provide significant influence and impact on the quality and compliance of computerized systems utilized within clinical trials.
They autonomously assess technology, data integrity controls, and regulatory compliance, recommending necessary changes to ensure adherence to standards when deviations or non-compliance are identified.
Technology Quality Auditors also provide guidance on best practices and address compliance issues through discussions with sponsors, third-party suppliers, and internal stakeholders.
Travel is infrequent, maximum 20% of your time.
Accountabilities: Lead Third-Part Supplier and Internal Technology Audits Prepare for, Conduct, Report on, and Follow-up on findings from audits Support Serious Breach investigations Support Auditor Training and Mentoring Maintain QA Records / Systems Support Sponsor Audits and Regulatory Inspections Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote a culture of quality and compliance within Parexel Build, develop, and maintain working relationships with internal and external customer groupsSkills: Excellent interpersonal, verbal and written communication skills Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Experience with Microsoft based applications and ability to learn internal and supplier computer systems Willingness to work effectively with minimal supervision in a matrix environment and to value the importance of teamwork Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives Ability to work professionally with highly confidential information Flexibility and ability to adjust to changing priorities and unforeseen events Excellent time management skills and the ability to follow-up on multiple tasks and projects Ability to diplomatically address sensitive issues confidentially and professionally Ability to work consistently in a fast-paced environment Knowledge and Experience: Strong knowledge of Gx P regulations and guidance, industry standards, and best practices for data integrity and technology used to support clinical trials.
Familiar in processes specific to the development, validation, maintenance, and use of technology within clinical trials, including Software Development Lifecycle (SDLC), Test Management, Change Control, etc.
Five to nine years of in Technology Quality Assurance Auditing, and/or relevant Technology Quality Management experience Education: Educated to degree level (information technology, information systems, biological science, or other related discipline preferred) or equivalent qualification or clinical research experience ASQ CQA and or CISA preferred
reklama
Senior Quality Assurance Auditor, Czech Republic
Czech Republic, Czech Republic, Czech Republic
Publikováno 2025-02-05
Vyprší 2025-02-04
ID #2587741985
Free
Senior Quality Assurance Auditor, Czech Republic
Czech Republic, Czech Republic, Czech Republic,
Publikováno February 5, 2025
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PAREXEL International is a leading global biopharmaceutical services provider, which continues to be a premier, trusted partner to clients who rely on the Company for expertise and flexibility, as well as the efficiencies of a worldwide infrastructure, to help them more quickly achieve their development and commercialization goals. For 30 years, PAREXEL has complemented client organizations with strategic insight, deep scientific knowledge, tactical expertise, and a wealth of experience throughout the development process. The Company's offerings include worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and integrated commercialization services. PAREXEL is focused on providing tailored solutions that match a client's specific needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality needed to help them bring safe and effective treatments to patients sooner.
Headquartered near Boston, Massachusetts, PAREXEL operates in over 70 locations throughout more than 50 countries, and has over 11,000 employees worldwide.
Visit www.PAREXEL.com for more information.
Specialties
Regulatory and product development consulting,
early phase clinical research,
phase II-III clinical research,
late phase clinical research,
eClinical solutions,
patient and site recruitment,
clinical logistics,
flexible outsourcing models,
strategic partnering