Senior AssociateDigital Manufacturing CSV-CSA
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Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Industry/Sector
Not ApplicableSpecialism
OperationsManagement Level
Senior AssociateJob Description & Summary
At PwC our people in operations consulting specialise in providing consulting services on optimising operational efficiency and effectiveness. These individuals analyse client needs develop operational strategies and offer guidance and support to help clients streamline processes improve productivity and drive business performance.In product development and manufacturing at PwC you will specialise in improving product development and manufacturing processes. You will work closely with clients to analyse product development lifecycles identify bottlenecks and develop strategies to enhance speed to market reduce costs and improve quality. Working in this area you will also provide guidance on implementing lean manufacturing principles optimising supply chain integration and leveraging digital technologies.
JOB OVERVIEW
PwC US ADVISORY - Senior Associate CSV/CSA (Pharmaceuticals & Life Sciences Advisory)
The Senior Associate CSV/CSA will support delivery of global consulting engagements in Computer System Validation (CSV) and Computer Software Assurance (CSA) across the Pharmaceuticals Life Sciences and Medical Devices sectors.
The role involves hands-on execution of validation deliverables supporting client workshops and managing defined workstreams within larger validation programs. The candidate will work closely with project leads and managers to ensure quality compliance and on-time delivery of outcomes.
POSITION REQUIREMENTS -
Validation Delivery & Execution- Execute and review CSV/CSA deliverables including Validation Plans User Requirements (URS) Functional and Design Specifications Risk Assessments Test Scripts (IQ/OQ/PQ SIT/UAT) Traceability Matrices and Validation Summary Reports.
- Apply risk-based validation and CSA principles to optimize effort while maintaining compliance with GAMP 5 21 CFR Part 11 and Annex 11.
- Support end-to-end validation for ERP MES LIMS eQMS and data integrity systems ensuring adherence to GxP and data integrity standards.
- Identify gaps in client processes and propose remediation or improvement actions aligned with regulatory expectations.
- Identify gaps in client processes and propose remediation or improvement actions aligned with regulatory expectations.
- Ensure all validation documentation meets regulatory and client-specific quality standards.
- Support inspection readiness audit preparation and CAPA/deviation closure activities.
- Maintain strong grounding in GxP Quality Management Systems (QMS) Digital Quality Systems (eQMS) and Computer System Assurance frameworks.
- Participate in quality risk assessments deviation management and CAPA reviews to support compliance and continuous improvement.
- Work collaboratively with cross-functional client and PwC teams (Quality IT Regulatory) during project execution.
- Support client workshops and meetings to gather requirements review deliverables and present progress updates.
- Review work products of junior associates ensuring completeness consistency and adherence to PwC quality standards.
- Operate in both project-based and managed service environments supporting ongoing validation and periodic reviews.
- Participate in internal initiatives templates and accelerators for validation documentation and CSA adoption.
- Contribute to team training peer review sessions and development of reusable playbooks.
- Stay updated on evolving FDA and EMA guidance related to CSV CSA and digital quality transformation.
Skills Preferred:
- Technical / Domain
- Strong grounding in GxP Quality Systems Computer System Validation (CSV) Computer Software Assurance (CSA) and Digital Quality Systems (eQMS).
- Hands-on experience in risk assessments CAPA deviation management validation testing and quality remediation.
- Knowledge of cGMP GxP FDA 21 CFR Part 11 and Process Validation (IQ/OQ/PQ).
- Familiarity with Operational and Scientific Excellence (OSE) yield improvement and maintenance/reliability programs.
- Experience implementing or validating Veeva Sparta or similar eQMS platforms or pharma shop-floor systems (e.g. MES LIMS ERP).
- Consulting / Delivery
- 36 years of relevant experience in Pharmaceuticals Life Sciences or Medical Devices domains.
- Experience in executing or supporting 12 full lifecycle CSV/CSA implementations (preferably also operated in a managed service environment).
- Strong documentation and technical writing skills with a focus on accuracy traceability and audit readiness.
- Ability to manage assigned workstreams coordinate with cross-functional teams and meet delivery milestones.
- Effective verbal and written communication with clients and internal stakeholders.
Educational Background:
- MBA (Tier-2 or above) with relevant CSV/CSA background OR . / . / Life Sciences degree with strong experience in validation and regulatory compliance.
Additional Information
- Travel Requirements: Travel to client locations may be required as per project requirements.
- Line of Service: Advisory
- Specialism: Physical Product Development & Manufacturing CSV/CSA
- Designation: Exp. Associate / Senior Associate
- Location: Bangalore India
- Past Experience: Senior Associate (4-7 years) of prior relevant work experience
- Preferred Work Experience: Validation/ Testing experience in Pharmaceutical & Life Sciences (PLS including Medical Devices and Health Industry Advisory) preferred
Travel Requirements
Not SpecifiedJob Posting End Date
January 23 2026Required Experience:
Senior IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
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
