Manager - CSV - IT

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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager - CSV - IT

Job Description

The Manager CSV – IT is responsible for ensuring validated, compliant, and audit ready computerized systems across the organization in line with regulatory, data integrity, and quality requirements. The role provides centralized ownership for Computer System Validation (CSV), IT compliance documentation, supplier assessments, and regulatory audit readiness for enterprise and shop floor systems across corporate and site locations.

Key Responsibilities

• Computer System Validation (CSV)
• Maintain strong practical understanding of Computer System Validation (CSV) for enterprise applications and manufacturing / quality systems.
• Ensure CSV compliance across all phases of the software lifecycle including project implementation, operational use, and system retirement.
• Apply global regulatory standards including GAMP 5, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.
• Work closely with CSV and Project Managers to ensure validation milestones align with project timelines.
• IT Infrastructure & Qualification Documentation
• Prepare and review IT qualification documentation covering Network, Servers, Databases, Cloud infrastructure, and Manufacturing / Shop‑Floor ecosystems.
• Ensure infrastructure qualification evidence is complete, traceable, and audit‑ready.
• Support validated state maintenance through change control and periodic review activities.
• Quality Management System (QMS) Support
• Prepare and manage IT‑related QMS documents including Change Controls, Deviations, Incidents, Discrepancies, and User Access requests.
• Perform root cause analysis and define CAPA actions based on QMS records and audit findings.
• Ensure timely closure of quality actions with documented effectiveness checks.
• Periodic Review & Data Integrity
• Perform periodic reviews and audit trail reviews of computerized systems as per defined frequencies.
• Ensure ongoing adherence to data integrity principles including ALCOA+ requirements.
• Identify risks related to system usage, access controls, and electronic records.
• Supplier & Vendor Compliance
• Conduct IT supplier assessments and support vendor audits for CSV and IT compliance requirements.
• Track and ensure closure of audit observations related to IT systems and service providers.
• Maintain supplier compliance documentation in line with quality standards.
• Audit & Regulatory Support
• Represent IT CSV function during internal, corporate, regulatory, and data integrity audits.
• Perform corporate and data integrity audits across sites as required.
• Provide clear, evidence‑based responses to audit queries and observations.
• Cross‑Functional & Site Coordination
• Liaise with Site IT Compliance SPOCs for CSV activities and IT compliance initiatives.
• Support quality eCompliance and CSV initiatives across corporate and site locations.
• Act as a central coordination point for CSV governance and standardization.
• Training & Capability Building
• Guide and train IT and CSV teams at corporate and site levels on CSV, data integrity, and regulatory compliance.
• Promote validation best practices and compliance awareness across IT functions.
• ITIL & System Operations Awareness
• Apply knowledge of ITIL processes including Backup & Restoration, User Access Management, and Infrastructure Qualification
  
  

Ensure operational IT processes support validated state and regulatory expectations.

Bachelor of Engineering – Computer Science & Engineering