IT Manager - CSV / GxP Compliance: Savli

IT Manager - CSV / GxP Compliance: Savli

18 Oct
|
TopGear Consultants
|
Savli

18 Oct

TopGear Consultants

Savli

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.

1. 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.

2. 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.

- 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 transparent 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

.

if interested, Kindly share your updated resume at [email protected]

📌 IT Manager - CSV / GxP Compliance: Savli
🏢 TopGear Consultants
📍 Savli

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: it manager - csv / gxp compliance: savli / savli

Subscribe to this job alert:

Get the latest job offers by email for: it manager - csv / gxp compliance: savli / savli