IN_Senior Associate_CSV,QMS_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 Summary: 

We are looking for a motivated and detail-oriented Associate-level professional to join our Validation team. The ideal candidate will have a foundational understanding of Computer System Validation (CSV) and Instrument Qualification within regulated environments such as pharmaceutical, biotech, or medical device industries. This role involves supporting validation activities to ensure computer systems and laboratory/analytical instruments meet compliance standards and function as intended. 

Responsibilities: 

• Assist in the planning, execution, and documentation of Computer System Validation activities, including risk assessments, functional specifications, design specifications, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

• Support instrument qualification activities for laboratory and manufacturing equipment (IQ/OQ/PQ protocols) ensuring compliance with regulatory requirements. 

• Participate in the review, update, and maintenance of validation-related documents, protocols, reports, and SOPs. 

• Collaborate with cross-functional teams including Quality Assurance, IT, Manufacturing, and R&D to ensure systems and instruments meet compliance and operational requirements. 

• Assist in performing gap analyses and impact assessments related to system changes or upgrades. 

• Support internal and external audits by preparing documentation and responding to audit queries. 

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 Technology

Degrees/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 24, 2026