CSV

CSV (Computer System Validation) ITRA

The opportunity

ITRA is one of the most important risks facing businesses today. Systems and processes are becoming increasingly interconnected and automated, and many organizations are now reliant upon technology to drive business strategy and growth. Our clients are overwhelmingly

turning to EY for help and guidance on how to protect their assets, minimize business disruption and improve security as they continue to exploit technology and the Internet of things.

As part of the team, you will be working on CSV, which provides our internal customers with a Technology recharge (bill) which is timely, defensible, and meaningful service-oriented and based on true cost and volume drivers. It is being used by technology and business

managers globally to view their individual areas technology spend.

Vacancy for Roles

The current vacancy is only for the roles of Associate Consultants/ Consultants/ Senior Consultants

.The role will be finalized based on experience of the candidate.

Your key responsibilities

• Perform assessments of computer systems and processes for Life Sciences clients

(compliance with internal procedures, leading practices, and regulatory requirements)

• Create/ review CSV deliverables like user requirements, system specifications,

Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design

Specs, and validation summary reports

• Provide guidance and oversight of validation activities for projects involving GxP

relevant computer systems

• Work closely with project team members to incorporate appropriate elements of

quality and compliance into the system lifecycle

• Review and approve computer system validation work products, assuring

thoroughness of validation planning and making appropriate progress towards timely

completion of validation deliverables

Skills and attributes for success

• Experience in Quality and Compliance with hands-on computer system validation

experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS etc.)

• Experience in FDA regulated environment with good understanding of cGxP (cGMP,

cGDP, cGAMP, cGLP) standards and Risk based validation.

• Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will

be an added advantage.

• Experience in training validation resources will be an added advantage.

CSV-ITRA

To qualify for the role you must have

• A graduate degree from a reputed University
• 3 - 13 years of overall CSV experience
• Hands on experience of 21 CFR/ CSV

Ideally youll also have

• Excellent written and verbal communication, interpersonal, networking, teaming and

problem-solving skills

• Be highly flexible, adaptable, and creative.
• Initiative in keeping abreast of changing industry practices, analysis and design

methods, tools and techniques and emerging technologies

• Willingness to work in different time-zones as required

What we look for

Highly motivated, you will be a good communicator with the ability to contribute confidently to

technical security discussions with peers and management. You will be a team player who is

not only looking to enhance their own career, but recognises the value in working well with

others and the value of teamwork.

What working at EY offers

EY is committed to being an inclusive employer and we are happy to consider flexible working

arrangements. We strive to achieve the right balance for our people, enabling us to deliver

excellent client service whilst allowing you to build your career without sacrificing your

personal priorities. While our client-facing professionals can be required to travel regularly,

and at times be based at client sites, our flexible working arrangements can help you to

achieve a lifestyle balance.

About EY

As a global leader in assurance, tax, transaction and advisory services, we hire and develop

the most passionate people in their field to help build a better working world. This starts with a

culture that believes in giving you the training, opportunities and creative freedom to make

things better. So that whenever you join, however long you stay, the exceptional EY

experience lasts a lifetime.

If you can confidently demonstrate that you meet the criteria above, please

contact us as soon as possible.

Join us in building a better working world. Apply now.