13 Oct
|
Sun Pharmaceutical Industries
|
India
13 Oct
Sun Pharmaceutical Industries
India
Job Summary
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Summary:
The Job holder will be responsible to managing QC laboratory systems, computer system validation, data integrity, and regulatory compliance across pharmaceutical manufacturing operations. Leads laboratory digitalization initiatives, ensures audit readiness, and provides end-to-end support for laboratory applications, instruments, and GxP-compliant computerized systems.
Demonstrates robust written and verbal communication skills to effectively collaborate with cross-functional teams, vendors, auditors,
and regulatory stakeholders.
Areas Of Responsibility:
• Administer and support laboratory informatics applications such as Empower, LabX, LIMS, CDS, and other GxP-regulated laboratory systems.
• Serve as Site Administrator for quality laboratory applications and provide support for multi-site deployments where applicable.
• Lead and support Computer System Validation (CSV) activities, including preparation, review, and execution of validation documents such as URS, Risk Assessments, Validation Plans, Configuration Specifications, Test Scripts, Traceability Matrices, and Validation Reports.
• Execute and oversee IQ, OQ, PQ, system upgrades, and periodic validation reviews.
• Manage operating systems, servers, workstations, and instrument-connected computers supporting laboratory operations.
• Ensure compliance with Data Integrity principles (ALCOA+), GAMP 5, 21 CFR Part 11, Annex 11, and company quality stand
📌 Manager- Quality Informatics (India)
🏢 Sun Pharmaceutical Industries
📍 India