Intas Pharmaceuticals
Website:
intaspharma.com
Job details:
Senior Manager – Quality Business IT Applications
đź“Ť Location: Matoda, Ahmedabad
Role Overview :
We are looking for a seasoned Senior Manager – Quality Business IT Applications to lead and manage Quality IT applications supporting Quality Assurance (QA) and Quality Control (QC) laboratories across multiple pharma manufacturing sites. The role will drive digital QMS transformation, Integration, ensure regulatory compliance, and lead digital automation initiatives within Quality operations.
- To Lead enterprise‑wide digital quality transformation
- To shape future‑ready Quality IT capabilities in a regulated pharma environment
- Cross‑functional and multi‑site exposure
Key Responsibilities :
- Lead and oversee Quality IT application portfolios including QMS, Document Management, Training, Validation, and QC Lab systems across sites.
- Ensure GxP compliance, data integrity, and seamless deployment of Digital QMS and QC Lab automation solutions.
- Act as the technical lead for multi‑site deployments and system validation in collaboration with IT‑CSV teams.
- Partner with Quality, Manufacturing, and Regulatory stakeholders to translate business needs into scalable IT solutions.
- Manage solution delivery, support teams, and vendors for both COTS and custom pharma applications.
- Drive program and project management activities—planning, execution, governance, and delivery.
- Lead automation, digitization, and continuous improvement initiatives within QA & QC processes.
- Ensure timely system upgrades, patches, and vendor governance.
- Manage multiple concurrent projects and deliver business outcomes independently.
Quality Applications Scope :
- QMS (Change, Deviation, CAPA, Market Complaints)
- Document Control & Record Management Systems
- Training Management System
- Equipment Qualification & Calibration Management
- Cleaning Validation System
- Forms & Format Tracking Systems
Technical Skills :
- Hands‑on experience in application development, server configuration, and end‑to‑end quality system solutions.
- Exposure to SAP modules (PP‑PI, QM, MM) and SAP PI interfaces with .NET‑based applications.
- Experience delivering regulated project documentation: URS, FRS, Risk Assessment, Testing, Training, Data Migration.
- Knowledge of Web, Windows, and Console Applications with strong troubleshooting skills.
- Programming exposure to C#.NET, VB.NET, .NET Core.
- Front‑end scripting: JavaScript, jQuery, Angular, Node.js, Bootstrap.
- Working knowledge of Databases and SQL (queries, procedures, triggers, indexing, jobs, backups).
- Experience with SSO, Active Directory, LDAP integration.
- Strong reporting, dashboarding, and data visualization skills.
Qualifications & Experience :
- B. Tech / B E / MCA / MBA or equivalent with relevant functional experience
- 12–15 years of experience in Pharma IT / Quality IT systems
- Strong domain expertise in QMS platforms and pharma regulatory compliance
- Experience leading multi‑site application deployments
- Sound knowledge of pharma regulations: 21 CFR Part 11, Annex 11, GAMP
- Proven ability to build strong relationships with business stakeholders
Click on Apply to know more.