CSV ConsultantPwC India
Sahakar Nagar, Bengaluru · 6-12 yrs · 10-15 LPA
As a CSV Consultant at PwC India, you will work within a client-facing delivery team to support organizations in the pharmaceutical and life sciences sectors. You will play a critical role in evaluating and remediating complex compliance gaps within manufacturing and QC environments. This position focuses on ensuring that digital systems and infrastructure align with global quality standards and regulatory requirements.
what you'll do:
- Conduct comprehensive gap assessments for GxP-regulated systems against 21 CFR Part 11 requirements.
- Develop and execute remediation plans for computerized systems to ensure regulatory compliance.
- Author and review validation documentation, including VMPs, URS, FRS, and IQ/OQ/PQ protocols.
- Partner with client stakeholders in manufacturing and QC departments to identify compliance risks.
- Manage the lifecycle of GxP system validation from project initiation through to final documentation.
- Provide expert guidance on data integrity and computer system validation best practices.
why join: PwC India provides the opportunity to work at the intersection of technology and compliance, allowing you to influence the operational standards of global leaders in the pharmaceutical and life sciences industries.
message me directly on tal BOSS.
tal saysjoin pwc india as a csv consultant to drive compliance strategies for gxp-regulated equipment and systems.
strategy
senior
Sahakar Nagar, Bengaluru
gxp21-cfr-part-11
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