INSenior AssociateCSV,QMSRC Internal AuditAdvisoryNoida
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Job Location:
Monthly Salary:
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
Line of Service
AdvisoryIndustry/Sector
FS X-SectorSpecialism
RiskManagement Level
Senior AssociateJob 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 forour 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 foreach 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 firms 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:
Assistin 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.
Assistin 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.validationlifecycle 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 communicationand interpersonal skills to work collaboratively across teams.
Ability to manage multiple tasks and prioritize workload effectively.
Willingness to learn and adapt in a fast-pacedregulated 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 withvalidationlife 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 ofGxPcompliance requirements including FDA 21 CFR Part 11 and EMA Annex 11.
Education qualification:
Bachelors 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 moreDesired Languages (If blank desired languages not specified)
Travel Requirements
Not SpecifiedAvailable for Work Visa Sponsorship
NoGovernment Clearance Required
NoJob Posting End Date
April 23 2026Required Experience:
Senior IC
About Company
At PwC, our purpose is to build trust in society and solve important problems. We’re a network of firms in 155 countries with over 284,000 people who are committed to delivering quality in assurance, advisory and tax services. Find out more and tell us what matters to you by vis ... View more
