Senior Associate - Computer System Validation and Instrument Qualification

IN_Associate_ITGC_RC - Internal Audit_Advisory_Noida

Line of Service

Advisory

Industry/Sector

FS X-Sector

Specialism

Risk

Management Level

Senior Associate

Job Description & Summary

At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.

Those in governance, risk, controls and compliance at PwC will be responsible for confirming regulatory compliance and managing risks for clients. Your work will involve providing advice and solutions to help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.

Why PWC

At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us.

At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations.

JOB DESCRIPTION 

ITGC Audits, IT Internal Audits, IT Controls Testing, IT SOX Testing, IT Application Controls, ERP (SAP, Oracle etc.) Control Reviews, IT Compliance Assessments (ISO 27001, NIST etc.) 

Position title: 

Associate_ITGC_GRC_Advisory 

Experience: 

2-4 years 

Location:  

G. Noida/ Bhuvaneshwar/ Kolkata 

Department: 

Risk Consulting - GRC 

Purpose of the Job /Role 

Perform ITGC Audits, IT Internal Audits, IT Controls Testing, IT SOX Testing, IT Application Controls, ERP (SAP, Oracle etc.) Control Reviews, IT Compliance Assessments (COBIT, ISO 27001, NIST, etc.) 

Responsibilities: 

 

 

 

• Prior experience working in an IT Internal Audit Team or consulting company specializing in conducting IT Audits, IT Internal Audits, ERP (SAP, Oracle etc.) Reviews, ITGC, IT Application Controls Reviews. 

• Strong understanding of IT General Controls domains such as Change Management, User Access Management, IT Operations, Back and Recovery Management, BCP/ DR etc 

• Strong understanding of IT Application controls (Input/ Output Controls, Processing Controls, Interface controls) specifically w.r.t. ERP applications such as SAP, Oracle etc. 

• Understanding of IT SOX Control Testing, Internal Financial Controls (IFC) Testing 

• Understanding of the third-party risk management reviews 

• Understanding of IT Risk Management frameworks such as COBIT, NIST, ISO 27001, etc. 

• Should understand complete audit lifecycle from audit scoping to project deliverables 

• Ability to carry out IT Audits/Assessments (with minimum supervision) including: 

• Understanding the client’s IT environment 

• Audit scoping considering critical systems and processes 

• Finalising Risk & Control Matrix, Data Requirements 

• Interview client stakeholders (mid-management level) 

• Conduct walkthrough meetings 

• Carry out test of design and operating efficiency of IT controls 

• Obtain relevant artefacts and identify exceptions 

• Discussion on observations/ issues identified 

• Drafting audit reports (Observation, Risk, Implication, Identify Action Owner, Timelines for closure) and presenting to key stakeholders 

• Strong knowledge and experience of MS Office Tools (Excel, Word, PowerPoint), Data Analytics Tool 

• Excellent communication and presentation skills and ability to effectively communicate observations/ issues at senior management levels 

Education:  

• Minimum Qualification: BE/ BTech/ CA (Intermediate) 

• Postgraduates in any stream would be preferred (not mandatory) 

• Prior Big 4 experience, consulting company, internal audit department would be an added advantage 

• Experience in IT Risk Assurance for varied industry segments preferred 

• Excellent communication skills - both written and oral 

 

Certifications: 

• CIA/CISA/CISM will be added advantage 

 

Mandatory skill sets: 

• Knowledge of CSV documentation and tools (e.g., validation lifecycle management software). 

• Proficient in Microsoft Office applications (Word, Excel, PowerPoint). 

• Familiarity with laboratory information management systems (LIMS) and manufacturing execution systems (MES) is a plus. 

• Ability to interpret technical documents, SOPs, and regulatory guidelines. 

Preferred skill sets: 

• Strong attention to detail and analytical skills. 

• Good communication and interpersonal skills to work collaboratively across teams. 

• Ability to manage multiple tasks and prioritize workload effectively. 

• Willingness to learn and adapt in a fast-paced regulated environment. 

Years of Experience required: 

• 1-3 years of experience in Computer System Validation and/or Instrument Qualification in regulated industries (pharmaceutical, biotech, medical devices). 

• Experience with validation life cycle documentation (User Requirements Specification, Functional Specification, Validation Plans, Test Protocols, Validation Reports). 

• Hands-on experience or exposure to qualification of instruments such as HPLCs, GCMS, balances, pH meters, or other laboratory/manufacturing equipment. 

• Basic understanding of GxP compliance requirements including FDA 21 CFR Part 11 and EMA Annex 11. 

Education qualification:   

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field preferred. 

Education (if blank, degree and/or field of study not specified)

Degrees/Field of Study required: Bachelor of TechnologyDegrees/Field of Study preferred:

Certifications (if blank, certifications not specified)

Required Skills

Computer System Validation (CSV), Quality Management Systems (QMS)

Optional Skills

Accepting Feedback, Accepting Feedback, Active Listening, Analytical Thinking, Business Decisions, Business Performance Management, C-Level Presentations, Communication, Compliance Frameworks, Compliance Policies, Compliance Program Implementation, Compliance Review, Controls Testing, Corporate Governance, Creativity, Embracing Change, Emotional Regulation, Empathy, External Audit, Finance Target Operating Model, Finance Transformation, Financial Reporting, Fraud Detection, Fraud Prevention, Group Facilitation {+ 18 more}

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Not Specified

Available for Work Visa Sponsorship?

No

Government Clearance Required?

No

Job Posting End Date

April 23, 2026

Experience Level

Entry Level