IT Manager - CSV / GxP Compliance: Savli

TopGear Consultants Pvt Ltd.; Savli; In loco; INR 1.500.000 - 2.300.000; Tempo pieno

Descrizione del lavoro

Leading Pharmaceutical Company in Savli is seeking an IT Manager to lead end-to-end IT projects, oversee application and service support, and ensure regulatory compliance in a GMP environment.

The role requires managing budgets, vendor relations, and PMO governance while delivering IT services that meet strict GxP standards and data integrity expectations.

Competenze

• Educational qualifications mandatory as listed (B.E./B.Tech or MCA).
• Postgraduate qualification (MBA/PGDM in IT or Operations) desirable.
• Certifications preferred: PMP/PRINCE2, ITIL v4 Foundation; exposure to CSV/GAMP5 training is an advantage.

Mansioni

• Plan, execute and govern IT projects end-to-end, including scoping, business case, timelines, resourcing and risk management.
• Govern application and infrastructure service support against defined SLAs and drive issue resolution and improvements.
• Coordinate computer system validation (CSV) activities, URS, IQ/OQ/PQ and traceability for regulatory compliance.

Formazione

B.E./B.Tech in Computer Science, Information Technology or Electronics, or MCA (mandatory)

MBA / PGDM – IT or Operations (desirable)

PMP / PRINCE2, ITIL v4 Foundation; CSV / GAMP5 training (advantage)

Descrizione del lavoro

Opening with a leading Pharmaceutical Company for their office at Savli location

Role: IT Manager

Roles & Responsibilities:

• 1. IT Project & Programme Management
  • Plan, execute and govern IT projects and technology initiatives end-to-end scoping, business case, timelines, resourcing, risk and issue management.
  • Ensure on-time, within-budget delivery and track defined business objectives and benefits post go-live.
  • Run project governance forums, status reviews and stage-gate approvals with business and IT leadership.
• 2. Application & Service Support Operations
  • Govern application and infrastructure service support against defined SLAs; monitor performance and drive corrective actions on breaches.
  • Own incident, problem and service-request resolution, including escalation management and root-cause analysis for recurring issues.
  • Plan support resources; enable users through training, knowledge articles and onboarding support.
  • Drive continuous service improvement using ticket analytics, user feedback and service-level trends.
• 3. IT Compliance, Validation & Access Management
  • Ensure IT processes and systems comply with organizational SOPs and regulatory requirements, including GxP, 21 CFR Part 11, EU Annex 11 and data-integrity (ALCOA+) expectations.
  • Coordinate computer system validation (CSV) activities validation plans, URS, IQ/OQ/PQ, traceability and periodic reviews in line with GAMP.
• 4. Stakeholder, Vendor & Budget Management
  • Act as the IT representative for cross-functional teams, translating business needs into technology requirements and solutions.
  • Manage IT asset procurement in coordination with Procurement and Finance requirement definition, evaluation, PO follow-up and asset lifecycle tracking.
  • Track IT budgets (capex and opex) against plan and flag variances; support annual budget preparation.
  • Coordinate with vendors and service partners on delivery, SLA performance, contract adherence and escalations; publish governance reports.
• 5. IT Controls, Audits & Documentation
  • Maintain IT general controls (ITGC) and ensure evidence is audit-ready for internal, regulatory and partner audits.
  • Own change-management records change requests, impact assessments, approvals, implementation and closure – per the change-control SOP.
  • Maintain operational documentation (SOPs, work instructions, system inventories, configuration records) to support business continuity and compliance.
  • Track audit observations and CAPAs to timely closure.
• 6. IT Governance, PMO & Performance Reporting
  • Establish and run PMO practices – project portfolio tracking, standard templates, prioritization and resource allocation across initiatives.
  • Define and report IT KPIs and dashboards (project health, SLA adherence, compliance status, budget utilization) to IT and business leadership.
  • Contribute to IT policies, governance frameworks and the technology roadmap to support organizational growth and operational excellence.
  • Guide and develop team members and vendor resources, setting clear goals and reviewing performance.

EDUCATION & EXPERIENCE

• Educational Qualifications B.E. / B.Tech in Computer Science, Information Technology or Electronics, or MCA (mandatory).
• Postgraduate qualification (MBA / PGDM – IT or Operations) desirable.
• Certifications preferred: PMP / PRINCE2, ITIL v4 Foundation; exposure to CSV / GAMP 5 training an advantage.

Relevant Experience

• 8–12 years of experience in IT, of which at least 3–4 years in IT project management.
• Experience in pharmaceutical, life sciences or other regulated (GxP) environments strongly preferred.
• Hands-on exposure to computer system validation, ITGC / regulatory audits and change control.
• Proven track record managing vendors, SLAs, IT budgets and asset procurement.