Job Title: Manager – Section Head (Validation / Qualification / CSV)

Location: Indore Plant

Department: Quality Assurance (QA)

Reports to: Head – Quality Assurance / Site Quality Head

Role Summary

We are seeking a highly experienced and self-driven professional to lead the Validation & Qualification section within the QA department. The incumbent will be responsible for overseeing end-to-end activities related to Process Validation, Cleaning Validation, Equipment & Facility Qualification, and Computer System Validation (CSV). This is a managerial role requiring robust cross-functional collaboration, team leadership, and audit readiness for domestic and international regulatory inspections.

Key Responsibilities

Strategic Planning & Oversight:

Lead the development and implementation of the site Validation Master Plan (VMP).
Oversee all validation and qualification activities (Process, Cleaning, Equipment, Facility, CSV) to ensure compliance with cGMP and regulatory expectations.
Allocate resources and manage workload for validation team to ensure timely execution.





Process & Cleaning Validation

Review and approve process validation protocols and reports in line with lifecycle approach.
Ensure cleaning validation activities meet regulatory expectations and site-specific risk assessments.
Support risk-based re-validation and continued process verification programs.

Equipment / Facility / Utility Qualification

Oversee IQ, OQ, PQ of new and existing equipment, HVAC systems, and utilities.
Ensure periodic requalification and deviation handling.
Review and approve all qualification documents and summary reports.

Computer System Validation (CSV)

Ensure GxP software and computer systems are validated as per GAMP 5 and 21 CFR Part 11 requirements.
Collaborate with IT, Engineering, and external vendors for new system qualification, periodic reviews, and change management.
Review and approve CSV documentation (URS, RA, IQ/OQ/PQ).

Compliance & Audit Readiness

Ensur

📌 Asst. Manager (Indore)
🏢 Sava Healthcare
📍 Indore