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Thứ Ba, 14 tháng 4, 2015

Computer System Validation (CSV) Associate - Deloitte - Boston, MA

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Deloitte & Touche LLP's ("Deloitte & Touche") Audit and Enterprise Risk Services business has a risk-based approach, experienced professionals, comprehensive methodologies, and technical resources. Deloitte & Touche's services combine competency and experience in the areas of financial reporting, risk management, and compliance providing security across the enterprise.

Business models today encourage, and even require, opening boundaries between customers, suppliers, and partners. Technology can enable that openness and is also seen as a means to help achieve compliance with corporate and governmental policies and regulations. However, behind this increased accessibility and reliance on technology exists real risks and challenges. Complex network environments, global operations, and human beings often challenge an organization's security efforts. The increasing imminence and complexity of security threats indicate that security has become a business imperative. Managing information risk at the enterprise level enables companies to achieve more efficient and effective security processes and programs. Issues such as stakeholder value, consumer confidence, brand and reputation protection, and legal and regulatory compliance can be addressed. To succeed in today's network driven economy, organizations have to expand their focus on IT, to include security strategy and management.


We are looking for a Computer Systems Validation Associate who is Experience in Life Sciences Industry, functional knowledge of Pharmaceuticals,Biologics,Medical Devices &Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite. The description of this position is:


Ø Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.


Ø Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing.


Ø Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)


Ø Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual).


Ø Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities.


Ø Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports.


Ø Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline.


Ø Accurately report the status of assigned deliverables and support other compliance work as necessary


Qualifications


Ø MUST HAVE


· Experience with IT Systems lifecycle (development, testing, implementation) ‑ Quality assurance domain preferred


· Knowledge of software testing


· Exposure to cross functional teams (lead, co-ordination)


· Ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude


· Attention to detail, quality, time management and customer focus


· Interpersonal and ability to operate effectively in a matrix environment


· Ability to write, read, and understand business as well as technical requirements


· Experience with MS Office applications including: Word, Excel, PowerPoint


Ø NICE TO HAVE


· At least 3 years of computer system validation in a pharmaceutical/medical devices environment


· Experience in the validation of software tools in a FDA regulated environment.(e.g., SAP, SAP Solution Manager, and HPQC.)


· Knowledge of regulations and software lifecycle approaches 21 CFR Part 11 and ,QSR's, ISO 13485, 21 CFR part 11,820,807,803 GAMP, SDLC methodologies)


· Experience in development of Validation Master Plans for simple systems or facilities.


· Experience in Project execution within at least one area of systems validation ‑ e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems.


Deloitte is one of the leading professional services organizations in the United States, specializing in audit, tax, consulting, and financial advisory services with clients in more than 20 industries. We provide powerful business solutions to some of the world’s most well-known and respected companies, including more than 75 percent of the Fortune 100.


At Deloitte, you can have a rewarding career on every level. In addition to challenging and meaningful work, you’ll have the chance to give back to your community, make a positive impact on the environment, participate in a range of diversity and inclusion initiatives, and find the support, coaching, and training it takes to advance your career. Our commitment to individual choice lets you customize aspects of your career path, your educational opportunities and your benefits. And our culture of innovation means your ideas on how to improve our business and your clients’ will be heard.


About Deloitte


As used in this document, “Deloitte” means Deloitte LLP and its subsidiaries. Please see http://ift.tt/RI86rD for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.


Disclaimer: If you are not reviewing this job posting on our Careers’ site (careers.deloitte.com) or one of our approved job boards we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at careers.deloitte.com.







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