EY Senior Consultant - Business Consulting Risk 

India, Karnataka, Bengaluru 

902245241

TMT :

Industry convergence offers TMT (Technology, Media & Entertainment, and Telecommunications) organizations the chance to evolve and transform, but it also presents challenges around competitiveness and delivering agile corporate strategies for growth.

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, SAP, 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.

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 you’ll 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 we look for

People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful and able to sustain postivie energy, while being adaptable and creative in their approach.

What we offer

If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible.