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Senior CSV Specialist
2 months ago
Job Summary:
Piramal Pharma Solutions is seeking a highly skilled Senior CSV Officer to lead our Computerized Systems Validation (CSV) activities. As a key member of our Quality team, you will be responsible for ensuring the validation of GxP computerized systems, providing guidance and training to site teams, and managing vendor resources.
Key Responsibilities:
- Manage GxP IT System Validation: Oversee the validation of GxP IT systems, including HMI/PLC/SCADA/DCS/SaaS/IaaS, to ensure compliance with regulatory requirements.
- Project Planning and Tracking: Develop and maintain CSV project plans and track progress to ensure timely delivery of validation activities.
- Deliverable Review and Approval: Review and approve CSV deliverable documents received from vendors or prepared by internal IT/Quality teams.
- Digitization and Automation: Support and lead digitization and automation projects for site quality/IT/manufacturing processes as required.
- IT Supplier Audit and FAT: Participate in IT supplier audits and FAT of equipment/instruments used in GxP environments.
- Computerized System Inventory: Manage the computerized system inventory at site for GxP systems.
- Regulatory Compliance: Ensure 21 CFR Part 11 and EU Annex 11 compliance for IT systems.
- Data Integrity: Participate in data integrity assessments across the site, providing CSV input.
- Quality Risk Management: Actively participate in quality risk management, including gap analysis and remediation planning for GxP IT systems with site quality.
- Subject Matter Expert: Act as a subject matter expert for CSV projects, guiding and training site IT teams on CSV, data integrity, and regulatory IT compliance activities.
- IT QMS Document Review: Review IT-related QMS documents, such as change control, deviation, incidents, SOPs, etc., and provide inputs for CSV.
- Timely Closure: Ensure timely closure of IT/CVS-related change control, deviation, incidents, CAPA, observations at site.
- Continuous Improvement: Participate in continuous improvement initiatives within quality.
Requirements:
- Excellent coordination and communication skills.
- Ability to work with external and internal stakeholders, including vendors, clients, quality, project management, operations, and purchasing.
- Strong knowledge of GxP computerized systems and regulatory requirements.
- Ability to lead and manage CSV projects.
- Excellent problem-solving and analytical skills.
What We Offer:
Piramal Pharma Solutions offers a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development.
